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Aug 2016


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Medical Device Software - do you understand how software is regulated? - By AtoZ Compliance

Online Event


Key Take Away:

Learn the use of the FDA compliance, GAMP guidelines, 21 CFR Part 11 compliance, and other applicable industry software validation models, coupled with the ISO 14971 risk management / ICH Q9 quality risk management models, and their real-world implementation as requirements in medical device software.


The medical device software / firmware is a high risk component of mission-critical medical devices. Its use is increasing. As such it comes under increased scrutiny by the U.S. FDA. Hence medical device software training is gaining in relevance.

This webinar will primarily address the requirements in its regulation by the U.S. FDA. It will also consider key issues in the EU for CE-marked products. Key requirements under 510(k)s, IDEs and PMAs, will be evaluated, together with applicable guidance documents. Use of the FDA compliance training, GAMP, 21 CFR Part 11 compliance, and other applicable industry software validation models, coupled with the ISO 14971 risk management / ICH Q9 quality risk management models, and their real-world implementation as requirements in compliance will also be considered. A field-tested SW V&V documentation “model” to meet these requirements will be also be discussed.

Why Should You Attend:

Software /firmware have become pervasive in medical devices themselves, and as “devices”. Serious injuries / death caused by critical high-risk devices such as pumps can often be traced to software / firmware malfunctions. Software is being developed for medical imaging, and even thought control of computers for individuals having disabilities restricting hand or eye movement / coordination.

The U.S. FDA rightly recognizes that virtually all software quality problems occur in the design, testing and validation phases, since replication of software is relatively defect-free. Consequently its submission processes reflect greater concern for the proper documentation and review of such software. Regulatory / submission auditors are more comfortable with delving into software issues. Field problems show the dangers of neglecting thorough, and risk based, software verification and validation activities. Effective and real world software documentation to prove compliance to requirements is mandatory.

This webinar will present material that is readily adaptable to the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries.

Areas Covered In This Webinar:

Medical software / firmware is coming under increased scrutiny by the U.S. FDA. This webinar will address the applicable 510(K), IDE, PMA requirements, and recommended guidance documents that drive the U.S. FDA’s expectations for and evaluation of submission documentation and marketing justification for devices containing software / firmware.

Additional review of GAMP guidelines, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software documentation models, coupled with the ISO 14971 Product Risk Management models, to structure, run, and document acceptable software development, V&V and submission considerations. The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if “risk-based”. How can this be done in the "real world".

This webinar will focus on field-tested (FDA and EU) approaches that work. The OEM manufacturer is responsible to identify these requirements and implement them into an effective software development, V&V, documentation and submission process, to include “life cycle” considerations, to include the holding of their suppliers to such requirements, or develop complementary systems to supplement.

Learning Objectives:

FDA Documentation and Regulatory Expectations
Proven Development, V&V, submission documentation recommendations
“Must Have” Documentation
ISO / GAMP / Other Considerations

Who Will Benefit:

QA/RA Professionals
R&D Professionals
Engineering Professionals
Production Personnel
Operations Personnel

Speakers Profile:

John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years' experience in U.S. FDA regulated industries, 19 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).

For more detail please click on this below link:

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