Article on “Statistical Sampling Plans for Medical Devices”

One of the important aspects of design control of medical devices is statistical sampling plans for medical devices. To gain an understanding of the idea of statistical sampling plans for medical devices, one needs to understand the process of medical device design controls.

Statistical sampling plans for medical devices needs to be seen in this background: Under Sec. 820.30 of Title 21 of Code of Federal Regulations (CRF) the FDA sets out requirements from medical device manufacturers -which want to market certain categories of medical devices in the US -for establishing and maintaining procedures to implements design controls into the device.

An understanding of design controls is necessary first

First of all, what are design controls? Design controls are linearly and logically described and recommended steps that manufacturers have to take for ensuring that they have developed what they meant to develop. In addition, design controls have to also be implemented to ensure that the final product is in line with the expectations and needs from the customer’s perspective.

Statistical sampling plans for medical devices come at a slightly later stage. Design controls pave way for the validation processes of design verification and design, which are done to ensure that the device design has met critical specifications or outputs and fulfill the requirements for the safety requirements, intended use, or specified application.

Verification and validation

This stage makes way for the next, which is fulfillment of design verification and validation (V&V), as required under Sec. 820.50 of 21 CFR. A core part of this code is the requirement from manufacturers for establishing and maintaining procedures to locate valid and proper statistical techniques for the process capability and product characteristics to be considered applicable. These are what constitute statistical sampling plans for medical devices

More of rule of thumb

Statistical sampling plans for medical devices need to be written and based on a well-established statistical foundation. However, the FDA does not prescribe a formal plan for writing down statistical sampling plans for medical devices. These are to be based more on rule of thumb. In other words, there are no acceptable limits violations under statistical sampling plans for medical devices. The statistical sampling plans for medical devices need to be implemented on a case-to-case basis, based on the device’s characteristics and features.

In arriving at statistical sampling plans for medical devices, the FDA sets out the following rule:

Table 1

Binomial Staged Sampling Plans

Binomial Confidence Levels

able 2

Binomial Staged Sampling Plans

Binomial Confidence Levels

ucl = Upper Confidence Level

Source:http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm170830.htm

These constitute the core guidance for statistical sampling plans for medical devices.

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Medical device companies need to get their design controls right

Design controls are among the most frequently cited areas for 483 and Warning Letter observations from the FDA, despite the regulatory agency considering this area as critical. It goes without saying that Design Controls are indispensable for ensuring the safety and effectiveness in the production of medical devices. Statistics show that a substantial percentage of all medical device recalls are due to design problems. This is despite the fact that intrinsic quality, safety, and effectiveness of a device are known to be established during the design phase.

When Design Controls are not built strongly enough into the medical devices, these are some of the implications:

o  Design Control flaws are a reason for a significant number of recalls

o  Design Control issues lead to complaints and medical device reports

o  When Design Control is not properly put in place, the manufacturer can face issues related to manufacturability, like low yields and excessive scrap and rework.

The solution is getting trained on Design Control issues and understanding the ways of implementing them

Given the severity of Design Control issues, medical devices manufacturers need to address the problem with one solid solution: Understand how to locate and fix issues early on in the design process. If this is not done, the consequences can be expensive. Finding and fixing problems for medical devices that are already in production is must more expensive than doing so at an earlier stage. What is more; such a process can also make the Design Control less effective.

How do medical device companies ensure a Design Control process that is free of hassles and will serve the primary intention for which it is to be implemented? This is the teaching a two-day seminar that is being organized by GlobalCompliancePanel, a highly regarded provider of professional trainings for the regulatory compliance areas, will impart.

At this seminar, Susanne Manz, an accomplished leader in the medical device industry, who emphasizes quality, compliance, and Six Sigma and brings extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities, will be the Director.  In order to gain insights into how to imbibe Design Controls into the earliest possible stages of medical device manufacture, please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900852SEMINAR?linkedin_SEO to register for this seminar.

This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

An important session on Design Controls

The main intention of this seminar is to provide a clear and deep understanding of the nature and importance of Design Controls in medical devices, and the ways of developing Design Controls processes and tools that are compliant with the regulatory requirements. Susanne will offer these to ensure that they become a competitive strength for their organizations. With this learning, participants can learn from past issues and mend their next generations of product.

An explanation of the requirements for design controls and an understanding of how to translate them into an efficient and effective process for their organizations will be given. Susanne will begin with the history and requirements for Design Controls. The next topic she will take up in detail is the requirements and tools needed to ensure product quality, while also meeting business needs for speed to market.

Also included are exercises to help participants practice what they have learnt here theoretically. At the end of this two-day session, participants will have gained the knowledge needed to improve their design control process.

Susanne will cover the following areas at this seminar:

o  Expectations

o  Regulations and History

o  Design Control process, procedures, forms, records, files

o  Linkages to the rest of your Quality Management System

o  Lessons Learned

o  Myths

o  Challenges

o  Best Practices

o  Inspection Readiness.

GlobalCompliancePanel announces Seasonal offers for Professionals with Flat 50% OFF on all Seminars

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Yes, that is right. GlobalCompliancePanel’s seminars will be available for a huge 50% discount till April 30. Regulatory professionals who want to augment their knowledge of regulatory compliance can now do so by paying just half the price of these trainings from GlobalCompliancePanel. All that is needed to do walk away with a rare offer such as this is to visit https://www.globalcompliancepanel.com/seminar?wordpress_SEO and use MGCP50 Promo Code.

This offer is valid till April 30, 2017. Regulatory professionals who want to take any of GlobalCompliancePanel’s trainings can book their trainings for an area of their interest by this date. From April 1 onwards, this offer will cease, meaning that the original price will apply from then.

So, why is GlobalCompliancePanel offering this discount? It is for a simple, but profound reason: It wants to thank its huge customer base for the support they have been extending to this company over the many years for which it has been in business. During the course of the 10 years for which GlobalCompliancePanel has been in business, it has trained thousands of regulatory compliance professionals from around the world.

These professionals, belonging to such varied geographies as the US and Japan and India and Canada, have been able to meet their regulatory compliance challenges on account of these trainings. These trainings are relevant, focused and valuable, and are from some of the best known regulatory compliance Experts found anywhere on this planet.

It is these trainings that have been hoping these professionals in the regulatory compliance arena gain more insights into regulations from the FDA, the EMA and other such bodies around the world. These trainings have been consistently helping them to meet these challenges, as they give them a better and sharper understanding of the implementing these requirements.

These regulatory requirements can pose hurdles to the most experienced and brightest of regulatory compliance professionals in the medical devices, pharmaceutical, life sciences and food and biologicals areas, but not to those who undertake professional trainings from GlobalCompliancePanel. GlobalCompliancePanel’s panel of experts is here to help them overcome these challenges and hurdles.

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Design of Experiments (DoE) for Process Development and Validation

Design of Experiments (DoE) is a very important process development and validation component in several kinds of industries. DoE for process development and validation involves carrying out a number of tests recurrently and steadily over a period of time. Its responses are then observed.

DoE is important for process development and validation as it offers an understanding of the predictability and reproducibility of an experiment. Fundamentally, Design of Experiments for process development and validation seeks to rule out fluke or chance in the methods needed for bringing about control for a product.

DoE in medical devices

In the area of medical devices, guidelines for Design of Experiments for process development and validation are set out in the Global Harmonization Task Force (GHTF) Process Validation Guidance for Medical Device Manufacturers. This document offers guidance in the area of Design of Experiments for process development and validation by suggesting the exact areas in which design of experiments should be applied during Process Validation.

The GHTF guidance also suggests the use of both screening and response surface designs during Operational Qualification. It further requires Design of Experiments for process development and validation to be used during various phases of design controls. These include:

o  Design and development planning

o  Design verification

o  Design validation

o  Design transfer

o  Design changes.

Get a full understanding of Design of Experiments for process development and validation

The ways of approaching Design of Experiments for process development and validation will be topic of a two-day seminar that is being organized by GlobalCompliancePanel, a highly respected provider of professional trainings for the areas of regulatory compliance.

Jim Wisnowski, who is the cofounder of Adsurgo LLC and co-author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP, will be the Director at this seminar. In order to gain a full understanding of the principles and application of Design of Experiments for process development and validation; please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900794?linkedin-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.

All about Design of Experiments for process development and validation

This seminar will offer total and all-round understanding of all the aspects of Design of Experiments for process development and validation.

Process development studies need to be completed before a process control plan is developed as part of an overall risk management strategy. These process development studies help gain knowledge and understanding about the impact of variation in process parameters on the variation in the product quality characteristics of the product.

An explanation of the methods used

The methodology of Design of Experiments for process development and validation offers a means for identifying process parameters, which impact product quality (critical process parameters) and determine the functional relationship that links the process parameters to those critical quality attributes.

Design of Experiments for process development and validation uses screening designs such as 2k factorial and D-optimal designs to determine critical process parameters. Design of Experiments for process development and validation use response surface designs, such as Central Composite Designs (CCDs) and I-optimal designs for fashioning the functional relationship between those critical process parameters and the critical quality attributes.

A primer on statistical analysis

This seminar on Design of Experiments for process development and validation will present a primer on statistical analysis, during which it will focus on the methods required for analysis of designed experiments. Jim will then move on to the steps to a proper DoE, during the process of which he will demonstrate the nature and uses of important risk management tools such as Ishikawa and FMEA, which can be used pre and post DOE studies.

The Director will also teach how to generate and analyze multiple screening and response surface designs, and why and how each are used. After teaching participants how to present the results, Jim will explain how to update the risk management tools using the results of the studies.

This session on Design of Experiments for process development and validation will cover the following areas:

o  Identify critical quality attributes (CQAs) that will be used as responses in your designs

o  Utilize risk management tools to identify and prioritize potential critical process parameters

o  Identify critical process parameters and develop a functional relationship between those process parameters and your critical-to-quality attributes (CQAs) using both screening and response surface designs

o  Be able to design and analyze screening designs including a factorial, fractional factorial, and D-optimal design

o  Understand the need for adding center points to a design

o  Be able to design and analyze response surface designs including central composite designs (CCDs), Box-Behnken designs, and I-optimal designs

o  Present results of DOE studies

o  Use systematic understanding from DOE studies to update the control plan that is part of the overall risk management plan.

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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