Complaint Handling, Medical Device Reporting and Recalls

Complaint Handling, Medical Device Reporting and Recalls are important aspects of a medical device.

Complaint handling is a crucial element of any Quality System. If a complaint comes out from a user about a product after it has passed through FDA scrutiny, it is an indication that something needs to be looked at and that the complaint has to be addressed.

Putting in place an effective complaint handling system is an imperative for the medical device manufacturer and a requirement from the FDA. Complaints are an important indicator of the kind of products manufacturers release into the market. They are a very important standpoint from which devices are evaluated, investigated and analyzed, so that corrective action can be taken.

The complaint evaluation should serve as an indicator

A complaint handling system has to be put in place to help the manufacturer comprehend a gamut of issues concerning complaints. The validity of the complaint, the root cause of the complaint, and preventive action taken are important ones among these.

Look for the trend

Ignoring or glossing over complaints is something no medical device manufacturer that is serious about its business and is professional can afford to do. In fact, medical device manufacturers should look to complaints as being an important pointer of problems and issues with the design, use and/or manufacture of a product. It is possible that just one complaint that is fully investigated and properly handled could lead to corrective action from the manufacturer.

So, the trend is an important aspect of a medical device complaint handling system. The trend helps the manufacturer zero in on the specific cause for complaints. This, however, is not easy as it appears, because the medical device manufacturer may need to analyze a wide variety of complaints. It is only this comprehensive exercise that may sometimes lead to swooping in on a defect.

This exercise of spotting the trend is crucial for getting a hold of the precise locus of the problem in the Quality System. The trend could be anywhere ranging from the product to the labeling or to the packaging or its distribution.

Imparting understanding of Complaint Handling, Medical Device Reporting and Recalls

The important aspect of trend spotting in medical device recall and its associated aspects will be covered at an important learning session on this topic that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance.

At this two-day seminar, David R. Dills, Global Regulatory Affairs & Compliance Consultant who provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers, will be the Director. Full knowledge of all the aspects of medical device complaint handling can be gained by registering for this seminar. Please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900758?wordpress_SEO for this.

The MDR and the Recall

David will also take up other important aspects of the medical device Quality System: The MDA and medical device recalls. The Medical Device Reporting (MDR) is the FDA’s mechanism that enables it to receive adverse events about medical device from manufacturers, user facilities and importers. The MDR system is aimed at helping the agency detect and correct adverse events quickly.

User facilities such as nursing homes and hospitals are required to report suspected medical device related serious injuries to the manufacturer and suspected medical device related deaths to both the FDA and the manufacturers. In cases where there is no information about the manufacturer, these injuries have to be reported to the FDA itself.

The FDA has an elaborate reporting system for all categories of medical devices, such as manufacturers, user facilities, distributors and manufacturers. David will offer learning on all these aspects of complaint handling.

The Medical Device Recall    

The Medical Device Recall is the method by which a medical device is taken out from the market and/or corrected whenever the FDA determines that the device, if it is left to continue in the market, has the potential to cause anything from serious and adverse health consequences to death. One can understand Medical Device Recall as an action taken with the intention of addressing a problem with a medical device that has violated applicable FDA law.

These are the situations in which Medical Device Recalls happen:

1) Because of a defect in a medical device;

2) The device’s potential to pose a risk to health, or

3) When it has a defect and is a risk to health.

David will offer clarity on all these aspects of Medical Device Recalls.

Applying ISO 14971 and IEC 62304 to medical device software

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Risk management of software used in medical devices has to be implemented diligently, completely and correctly, scrutinizing the gaps thoroughly and correcting them right from the very start of product development. This is critical because of the following reasons:

  1. Medical products that have gaps or are implemented incorrectly or incompletely suffer serious ailments such as impediments or delays in production. Further, such products fail to get the required certification and/or approval;
  2. Given the close linkage between most activities and the development lifecycle; almost no activity can be isolated and performed with retrospective effect after detection of a gap. As a result, all the activities performed till the identification of gaps become unproductive and redundant. When this happens, the company has to start from the beginning, irrespective of the stage at which an anomaly gets detected, incurring huge delays and cost overruns.

The solution to these problems is to embed software risk management into the bigger scope of overall risk management. This is the only real solution to problems associated with faulty product development. Globally applicable standard requirements such as ISO14971 and IEC62304 are major guidelines that help medical device companies get the risk management of software used in medical devices right. These standards have made risk management central to and a mandatory component of almost any activity in the medical device industry.

Getting it right from start till finish

Regulatory requirements set out in ISO14971 and IEC62304 standards that deal with risk management of software used in medical devices need to be implemented in the right manner, if medical device companies have to clear regulatory hurdles and meet quality standards. Expert professional trainings that help them do this will give them an understanding of how to design, implement and test critical medical device software in a regulatory compliant environment.

All these will be part of a learning session that is being organized by GlobalCompliancePanel, a very well-known provider of professional trainings for the regulatory compliance areas. This two-day, live seminar will have Markus Weber, Principal Consultant with System Safety, Inc., who specializes in safety engineering and risk management for critical medical devices, as the course Director.

To gain the benefit of expert training from the Director of this seminar; please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900750?wordpress_SEO  to register.

Globally applicable standard requirements

Markus will explain the requirements set out by international consensus, reflected in globally applicable standard requirements such as ISO14971 and IEC62304, which has led to risk management being a mandatory component of almost any activity in the medical device industry.

Since the need to embed software risk management into the bigger scope of overall risk management is a critical aspect; Markus will introduce all the steps needed for designing, implementing and testing core medical device software in a regulatory compliant environment, even as they adhere to the principles of risk management. Another important learning Markus will impart is system level risk management and the resulting interfaces to software.

The safety case method

A well-established method for collecting and consolidating all safety related information together in one location, so that all risk related activities are comprehensively summarized, and the safe properties of a device demonstrated, is what is called the ‘Safety Case’ or ‘Assurance Case’ document.

Although as of now, the FDA requires this method for only infusion pump submissions; this system of documentation is almost certain to become standard practice in the future across all devices that come up for approval. At this course, Markus Weber will introduce the basic concepts and content of safety assurance cases. He will also explain and illustrate their utility for internal and external review of safety related information.

Tips for practical application of risk management principles

Real-life examples and proven tips and tricks that make the application of risk management practical and beneficial will be offered at this webinar. The Director will describe the system level issues of risk management as well as the increasingly important software related issues of critical systems.

He will introduce the concept of an assurance case to make the combined effort needed to design, implement and verify a safe device transparent. An important outcome of this learning is that it will help participants to meet and comply with regulatory requirements with highly lessened overheads and resource burdens.

Quality audits for the medical device industry

Quality management systems of medical devices have to go through well-defined quality audits. Medical device companies need to implement these in order to show compliance with quality.

ISO 13485 is the quality management standard for medical devices. Based on the process approach of this document and that of 21 CFR part 820 the Global Harmonization Task Force (GHTF) has set out processes for audits relating to the quality management systems of medical devices. The GHTF believes that insertion of quality management system requirements based on ISO 13485 is a first step towards global harmonization of medical devices. These guidelines are meant to lead regulators into articulating regulatory systems for medical devices.

Purpose of quality audits according to GHTF

The GHTF spells out the rationale for carrying out quality audits for the medical device industry. The benefits of carrying these out can be seen in the following:

  • Assurance that a high quality medical device will be made available
  • Quality audits for the medical device industry make available a harmonized, consistent standard that can be used by future generations
  • These audits are independent, verifiable and objective assessment of the manufacturer’s compliance with regulatory requirements
  • The results of these audits can serve as an important guide for marketing medical devices.

Definition of quality audit

GHTF describes the quality audit as the organizational responsibilities, processes, structure, resources and procedures taken to implement a quality management system.

What should the quality management system cover?

The QMS in a medical device organization should cover the following:

  • Control of documents
  • Control of records
  • Management review
  • Internal audits
  • Corrective and preventive action

General requirements for organizations that audit

GHTF lists a few general requirements from auditing organizations. These include:

Audit types

Apart from describing the audit scope and methodology in detail; the GHTF also has a description of the types of quality audits for the medical device industry. They are:

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Article on FDA 21 CFR Part 11 Compliance

FDA-regulated industries electronic signatures and other records are considered authentic. From 2007, a strong body of opinion has emerged challenging the stringency of these requirements, but nothing major has been diluted from these.

The regulations under FDA 21 CFR Part 11 Compliance set out criteria that the Food and Drug Agency (FDA) considers in order to deem electronic signatures authentic. The electronic records, electronic signatures, and handwritten signatures executed to electronic records of several FDA 21 CFR Part 11 Compliance sets out benchmarks by which FDA-regulated industries have to be compliant with the standards set out in FDA 21 CFR Part 11 Compliance to prove that these are authentic, safe and trustworthy. The operative factor is that the FDA has to consider these signatures as being on par with those done on paper.

Which industries are included in FDA 21 CFR Part 11 Compliance?

FDA 21 CFR Part 11 Compliance applies to nearly all FDA-regulated industries, including but not restricted to:

  • Medical device manufacturers
  • Drug makers
  • CROs
  • Biotech companies, and
  • Biologics developers

The Aim of FDA 21 CFR Part 11 Compliance

The aim of FDA 21 CFR Part 11 Compliance is to ensure that specified FDA-regulated industries such as those mentioned above (with specific exceptions) implement controls -which could include audits, audit trails, documentation, system validations, and electronic signatures -for software and systems involved in processing electronic data that are:

  • Required to be maintained by the FDA predicate rules or
  • Used to demonstrate compliance to a predicate rule. The FDA describes a predicate rule as any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. FDA 21 CFR Part 11 Compliance also applies to submissions made to the FDA in electronic format, such as a new drug application.

Which industries are exempt from FDA 21 CFR Part 11 Compliance?

Interestingly, exceptions are allowed within the same industry, based on the format of filing. For example, while FDA 21 CFR Part 11 Compliance applies to submissions made to the FDA in electronic format; it does not apply to a paper submission for the same made in electronic format, such as fax.

Also, FDA 21 CFR Part 11 compliance is not required for record retention for trace backs by food manufacturers. Similar to the logic used in the mode of filing as noted above; most food manufacturers are not otherwise explicitly required to keep detailed records, but when organizations keep electronic documentation for HACCP and similar requirements; this documentation must meet these requirements.

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Preparing premarket submissions that win regulatory approval

Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and FDA regulatory 510(k) clearance.

What makes preparing premarket submissions that win regulatory approval challenging? It is the fact, acknowledged by the FDA itself, that the PMA is the most stringent type of device marketing application required by the FDA. The PMA should be secured from the FDA before the company markets the medical device. The FDA gives its approval of the PMA for a Class II medical device only after it determines that all the elements necessary for assuring that the application has enough scientific confirmation that it is safe and effective for the intended uses it is going to be put to. Preparing premarket submissions thus is an onerous task by any stretch of imagination.

Another element of preparing premarket submissions that win regulatory approval

Another aspect of preparing premarket submissions is the 510 (k). The 510 (k) is essentially a kind of premarket submission that is made to the FDA to show that the device that a manufacturer intends to market is at least as effective and safe as a legally marketed device of its equivalence, already in the market, that is not subject to PMA. The FDA calls this principle the substantial equivalency (SE) and the device that is used as the reference for equivalence, the predicate device. The requirements governing SE are contained in 21 CFR 807.92(a) (3).

On top of all these, regulatory professionals have the responsibility of creating preparing premarket submissions that should not only convincingly demonstrate the ways of stating and explaining regulatory arguments for their device to the U.S. FDA reviewer for getting the approval; they should also be presentable and well-organized, without being cluttered or confusing.

Professional trainings for preparing premarket submissions that win regulatory approval

Given all these, it goes without saying that a completely thorough understanding and knowledge of the relevant U.S. FDA laws, regulations and requirements is absolutely necessary for regulatory professionals. This in-depth understanding can be had only from thorough training, which is indispensable if the medical device company is to win a clearance or approval.

The ways by which to do this is the core learning a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will impart. The Director of this seminar is Subhash Patel, a very senior regulatory professional and founder of New Jersey-based MD Reg Consulting LLC, which serves medical device industry clients in all aspects of global regulatory affairs specific to their needs.

To enroll for this highly valuable training session on how to successfully prepare 510(k)/Pre-IDE/IDE and PMA premarket submissions that secure clearances and approvals from the FDA, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900776SEMINAR?wordpress-SEO .  This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

The grasp needed for preparing premarket submission that win regulatory approval

At this seminar, Patel will demonstrate the grasp that regulatory professionals in the medical devices industry need for working with the FDA officials during the review and approval process of their submission. He will offer a complete understanding of the major aspects of FDA premarket submissions.

While knowledge of the regulatory process is one thing; medical device companies also need to know how to set and state regulatory arguments for their device in a most convincing manner to the FDA reviewer. This knowledge will be part of this course. In the process of explaining how to prepare premarket submissions that win regulatory approval; Patel will also offer tips and suggestions to participants on how to work effectively with the U.S. FDA officials during review and approval process of their submission.

During the course of these two days, Patel will cover the following core elements of how to prepare premarket submissions. He will explain the following:

o  History and background of U.S FDA Laws and Regulations

o  Classify Your Device

o  Choose the Correct Premarket Submission for your device

o  Compile the Appropriate Information for your Premarket Submission

o  Author and Prepare your Premarket Submission

o  Submit your Premarket Submission to the FDA

o  Interact with FDA Staff during Review and Approval

o  Complete the Establishment Registration and Device Listing

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm

Standard Operating Procedures are crucial documents in the regulatory industry

 

Standard Operating Procedures (SOPs) are very important documents that can make or break an organization in the regulatory industry. In simple terms, a Standard Operating Procedure, as suggested in its nomenclature, is a description of a specific operational procedure in which all the activities necessary to complete tasks that conform to established best practices, set regulatory requirements for the particular industry, and the relevant State or local laws provincial laws are explained. Many a time, a Standard Operating Procedure can be just a description of the organization’s own mode of doing things related to its business.

So, this description leads to the fact that since a Standard Operating Procedure is a detailed description of how things are to be done by an organization; any such document in the medical devices industry contains a list of step-by-step procedures the manufacturing organization lays down for producing its products. In a larger sense, an SOP is a complete depiction of all the practices followed by a business that has to meet the required quality and regulatory standards.

Get trained on how to write Standard Operating Procedures effectively

Given the acute importance of Standard Operating Procedures; it is important for regulatory professionals to get a clear idea of how to approach them by getting a thorough understanding of this concept. A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, is being organized to give a thorough understanding of how to write Standard Operating Procedures effectively for the medical devices industry.

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, who has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and who manages activities within the global regulatory and compliance space; will be the Director of this seminar.  To gain a clear understanding of the topic of Standard Operating Procedures for the medical devices industry, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900760SEMINAR?wordpress_seo . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A clear clarification of all the major issues and aspects relating to Standard Operating Procedures will be one of the core purposes of this seminar. Writing a Standard Operating Procedure should be simple, or at least, that is what it appears in theory. In reality though, writing Standard Operating Procedures or procedural documents is quite challenging in the regulated industries, because the Standard Operating Procedures have to take a whole host of procedures, processes, practices and factors into consideration.

The FDA requires “proof of establish” for writing Standard Operating Procedures

In order to make this easier, the Director of this seminar will make the participants of this seminar understand the cornerstone of writing Standard Operating Procedures, which for the medical devices industry, is what the FDA calls “proof of establish”. This is the foundation of FDA regulations and guidance documents for this industry, and consists of the entire array of activities pertaining to the practice of how to define, document (in writing or electronically) and implement that which is written.

Once this rationale for the Standard Operating Procedures is clear, the step-by-step set of instructions needed for performing a particular job or task in the regulated industries flows more easily.  This is the teaching David will instill at this seminar on Standard Operating Procedures.

Writing Standard Operating Procedures is not the end; implementing what is written is

This said, writing the set of Standard Operating Procedures is by no means the end of the work for regulatory professionals. Implementing that which has been created and are in the process of being created is much more vital. David will offer understanding of this aspect by presenting topics associated with how to write, format, execute, manage and globally harmonize Standard Operating Procedures. This is going to be explained keeping in mind the fact that SOP’s are the most popular documents audited by FDA and other Agencies, as well as by auditors and customers.

Standard Operating Procedures and GDP

This seminar on Standard Operating Procedures will also give a detailed understanding of Good Documentation Practices required by companies to ensure GMP compliance and the role played by Standard Operating Procedures in helping achieve the required level of compliance and quality.

This seminar will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The Director will show recent enforcement actions for Standard Operating Procedures related violations, most of which are documentation related. He will also emphasize the fact that Standard Operating Procedures work best when they are designed to achieve specific results, and will teach participants the ways by which to determine what business goals will be achieved through better management with Standard Operating Procedures and how those goals will be measured.

https://www.brampton.ca/EN/Business/BEC/resources/Documents/What%20is%20a%20Standard%20Operating%20Procedure(SOP).pdf

Management for Medical Device Industry

 

A look at these gigantic figures perhaps gives some perspective of the importance of document management for the medical device industry: The US total market for medical devices is valued at over $110 billion annually. It makes up nearly two fifths of the global market, and is expected to grow by over 20 percent by 2016.

While many global players sell into the American market, the over 6500 American medical device companies too, on their part, sell in the US and other markets.

It goes without saying that a market whose products are often complex and play a critical role in sustaining life for patients has to be highly regulated. For products sold in the American market, irrespective of whether they are manufactured domestically or overseas, a slew of regulations exist for a number of activities. Document management for the medical device industry is one of the core areas for which the FDA has regulations.

FDA and other regulations for document management for medical device industryThe FDA and other regulatory bodies have regulations and standards for GxP processes in the medical device industry. These include:

  • Quality System Regulation (QSR), which is outlined in 21 CFR Part 820, Current Good Manufacturing Practices (CGMP)
  • 21 CFR Part 11
  • ISO 13485, which relates to Quality Management System Requirements for medical devices
  • ISO 14971
  • Relevant sections of SOX, and
  • ISO 9000 standards.
What should a document management system for medical devices be like?Ideally, an electronic document management system for the medical device industry should integrate process management and document management in a simple and seamless manner. This is the real purpose of document management for the medical device industry. This document suite should be customizable and configurable. It should serve the following purposes:

  • It should help companies achieve regulatory compliance with required regulatory bodies and standards such as FDA, ISO and other regulations.
  • It should do this by automating and managing GxP processes in an efficient and cost-effective manner.
  • Communication between the functions of the company should be quick and efficient, and should allow access by designated persons.
  • Document management for medical device industry should be designed to ensure quality compliance and help companies enhance the performance of the GxP processes all through the product development lifecycle. The document management system for medical device industry should help companies have control over critical activities such as:
    • Design Control
    • Device history record
    • Mechanism for receiving and addressing complaints
    • A record of the corrective actions the company takes of these complaints
    • Note of nonconformances

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