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.

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.

Supplier Management Conference for Medical Device Manufacturing in HONG KONG

 

Overview:

Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment.

How well do you understand the requirements for supplier management?

Could you pass a regulatory audit or inspection without any issues?

This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program.

This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers’ location, supplier auditing techniques, and supplier issues in management review.

The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation.

Why should you attend:

Since FDA regulations do not allow them to audit your suppliers unless they make finished medical devices, they require that you have sufficient control over them. But from time to time the FDA makes a reinterpretation of what this means. This happened within the last f 5 years, so if you supplier management program is older than that, you need to make major changes in you supplier management program. This is why the Good Manufacturing Practice (aka Quality System Regulations) is called cGMP. The C stands for current, meaning what the FDA considers the current state of the art in the areas they regulate. Also European Notified Bodies also periodically update their expectations, and for suppliers this happened with the publication of a guidance document by the Notified Body Operations Group (NBOG).

This seminar will go into the details of the NBOG supplier guidance document and a GHTF (Global Harmonization Task Force) guidance that describes the current FDA expectation on supplier management.

One of the major things introduced in these guidance document, is the concept of Risk, and the use of identified risks as part of the evaluation and monitoring of suppliers.

This seminar will review requirements and expectation of the FDA and European Notified Bodies for supplier management, and then how to incorporate these into your own supplier management process.

Areas Covered in the Session:

  • Understand FDA QSR and ISO 13485 requirements for supplier management
  • Creating a Risk-based Multi-tier supplier classification system
  • Understand when suppliers have to register and list with the FDA
  • Defining and using supplier Metrics
  • Explain the link between design control and purchasing data
  • Develop an risk-based supplier management process
    • Incorporating supplier regulatory and safety risk
    • Incorporating supplier business risk
  • Create supplier measurement and monitoring systems
  • Understand the how to develop and implement supplier controls
  • Create a risk based Value-added system for supplier audits
  • How to prepare yourself and your contract manufacturer for unannounced audits from your Notified body
  • Creating acceptance criteria and understand how that fits into your supplier control process

Who will benefit:

  • Quality Managers
  • Quality Engineers
  • Audit Managers
  • Supplier Engineers
  • Internal quality auditors
  • Supplier auditors
  • Quality associates
  • Quality Specialists
  • Regulatory Compliance Managers

Agenda:

Day 1 Schedule

Lecture 1:

Introductions

Lecture 2:

Fundamentals Regulatory Requirements

  • FDA Requirements
  • ISO 13485 requirements
  • Understanding the role of the Global Harmonization Task Force Guideline
  • Understanding NBOC Guideline and why it should be used

Lecture 3:

Planning the Supplier Management Program

  • Supplier Classification
  • Supplier QA agreements what are they and why are then

Day 2 Schedule

Lecture 1:

Planning Supplier Selection

Lecture 2:

Potential Suppliers

Lecture 3:

Supplier Selection

Lecture 4:

Implementing Supplier Controls

Lecture 5:

Monitoring, Measuring, and Evaluation

  • Periodic Monitoring
  • Re-evaluations

Lecture 6:

Supplier Audits – where do they add value

  • Planning your supplier audit schedule
  • How Notified Body unannounced audits affect your contract manufacturer
  • What you should do to prepare yourself and your contract manufacturer for unannounced Notified body audits

Lecture 7:

Feedback and Communication

  • Supplier meetings: Partnering with Key suppliers
  • Supplier Corrective Actions

Lecture 8:

Evaluating your current program to see how it measures up to regulatory Expectations

Speaker:

Betty Lane,

Founder and President, Be Quality Associates, LLC

Betty Lane has over 30 years’ experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well for quality system requirements for other geographic area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate quality system processes for design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.

Betty’s training experience includes over 25 years of training on all aspects of ISO 13485, the ISO standard for Medical Device – Quality Management Systems – System Requirements for regulatory purposes, and FDA Quality System Regulation – Medical Devices; Good Manufacturing Practice (cGMP), in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical device and biotechnology quality and regulatory affairs as an Adjunct at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from Northeastern University.

Location: Hong Kong Date: April 6th & 7th, 2017 and Time: 9:00 AM to 6:00 PM

 

Venue: INTERCONTINENTAL HONG KONG

Address: 18 Salisbury Road, Kowloon, Hong Kong

 

Price:

 

Price: $1,695.00 (Seminar Fee for One Delegate)

 

Until February 28, Early Bird Price: $1,695.00 from March 01 to April 04, Regular Price: $1,895.00

 

Register for 5 attendees   Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*

 

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

 

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com

Website: http://www.globalcompliancepanel.com

Registration Link – http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900878SEMINAR?channel=mailer&camp=seminar&AdGroup=wordpress_April_2017_SEO

Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel

 

 

 

 

 

 

 

 

 

 

 

Medical Device Reporting and handling of recalls

Medical Device Reporting and handling of recalls are closely tied to each other. While medical device reporting is the first part, recalls are the next in a series of actions a medical device manufacturer could take in some circumstances.

Medical Device Reporting

Medical Device Reporting and handling of recalls are very important to the medical device industry. MDR is the FDA’s mechanism for receiving significant medical device adverse events from manufacturers, importers and user facilities. The point of having such a mechanism in place is that adverse events can be detected and corrected quickly. Medical device manufacturers need to be familiar with the finer aspects of the MDR. Apart from medical device manufacturers; user facilities such as hospitals and nursing homes are required to report suspected medical device related deaths to both the FDA and the manufacturers.

Recall

Recalls constitute another crucial component of the complaint handling system. Medical device reporting and handling of recalls complement each other, as can be seen from an understanding of this exercise.

A recall is a process by which a medical device is removed from the market or corrected whenever the FDA finds that there is a reasonable possibility that the device could cause any of these: serious, adverse health consequences or death. The link between medical device reporting and handling of recalls assumes greater significance when one considers what a recall means. In simple terms, it is an action taken to address a problem existent in a medical device that violates FDA regulation.

Recalls can happen in any of these three situations: a) when a medical device comes with a defect, b) the possibility that it could pose a risk to health is probably high, or c) there exists a combination of these two. Different rules for recall exist for different classes of medical devices. It is imperative for manufacturers to be familiar with these.

Thus, medical device reporting and handling of recalls constitute a core element of safety.

GlobalCompliancePanel

Medical Device Reporting and handling of recalls

Medical Device Reporting and handling of recalls are closely tied to each other. While medical device reporting is the first part, recalls are the next in a series of actions a medical device manufacturer could take in some circumstances.

Medical Device Reporting

Medical Device Reporting and handling of recalls are very important to the medical device industry. MDR is the FDA’s mechanism for receiving significant medical device adverse events from manufacturers, importers and user facilities. The point of having such a mechanism in place is that adverse events can be detected and corrected quickly. Medical device manufacturers need to be familiar with the finer aspects of the MDR. Apart from medical device manufacturers; user facilities such as hospitals and nursing homes are required to report suspected medical device related deaths to both the FDA and the manufacturers.

Recall

Recalls constitute another crucial component of the complaint handling system. Medical device reporting and handling of recalls complement each other, as can be seen from an understanding of this exercise.

A recall is a process by which a medical device is removed from the market or corrected whenever the FDA finds that there is a reasonable possibility that the device could cause any of these: serious, adverse health consequences or death. The link between medical device reporting and handling of recalls assumes greater significance when one considers what a recall means. In simple terms, it is an action taken to address a problem existent in a medical device that violates FDA regulation.

Recalls can happen in any of these three situations: a) when a medical device comes with a defect, b) the possibility that it could pose a risk to health is probably high, or c) there exists a combination of these two. Different rules for recall exist for different classes of medical devices. It is imperative for manufacturers to be familiar with these.

Thus, medical device reporting and handling of recalls constitute a core element of safety.

GlobalCompliancePanel