May 29, 2019
by Cindy Fazzi, Staff Writer, MasterControl
The U.S. Food and Drug Administration (FDA) plans to replace the Quality System Regulation (QSR) with ISO 13485. An announcement of a formal rule change is expected this fall, so GxP Lifeline asked three medical device industry experts and the Advanced Medical Technology Association (AdvaMed) to weigh the pros and cons of the plan.
February 14, 2019
by Cindy Fazzi, Staff Writer, MasterControl
For the medtech industry, 2019 is going to be marked by a slew of regulatory changes, beginning with Canada’s requirement of Medical Device Single Audit Program (MDSAP), which took effect on Jan. 1.
September 11, 2018
by Christine Park, Founder and Owner, Christine Park and Associates
Rather than viewing ISO as a burden, think of it as a standard upon which you can build a foundation for the sustainability and growth of your business. Learn how to use ISO as a catalyst to align a quality management system (QMS) with the strategic direction of your company.
July 31, 2018
by Tifany Desprez, Ph.D., Communication and Marketing Manager with MasterControl European Partner, Apsalys
France and Europe are witnessing an explosion of life science innovation from new startups. But what separates the winners from the losers? Learn how to successfully overcome regulatory barriers and get your product to market quicker.
January 16, 2018
by Michelle Lott, Principal and Founder, Lean RAQA Systems
This is the second post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide.” If you missed the first installment, catch up by reading it here. This post explores how the Practical Guide defines “risk-based approach,” varying terminology, and which systems require it.
September 12, 2017
by Christine Park, Consultant, Christine Park & Associates
Historically, the term “where appropriate” and/or “as appropriate” have been implied within the ISO 13485 standards as well as the FDA 21 CFR 820 Quality System Regulations. The FDA has always explained that “as appropriate” means it is appropriate unless you can justify why it isn’t appropriate.
March 2, 2017
Marci Crane, Staff Writer, MasterControl
For medical device manufacturers who plan to sell one or more products in Australia, Brazil, Canada, Japan and/or the U.S., the Medical Device Single Audit Program (MDSAP) is a valuable option for reducing regulatory burden while simultaneously demonstrating compliance against all regulations stipulated by the respective regulatory bodies of participating geographies.(1) According to the U.S. FDA’s MDSAP FAQ page “The MDSAP…is a program that will allow the conduct of a single regulatory audit of
February 2, 2017
by Lisa Weeks, Staff Writer, MasterControl
In early 2016, the International Standards Organization (ISO) published the long-awaited revised version of ISO 13485:2016, the standard which provides device makers with a framework for establishing a quality management system (QMS). Because it is the first major revision to the standard in 13 years, questions abound. In this post, we will tackle the most common questions asked by attendees during the many ISO 13485:2016-centric webinars we offered last year. We will also tap into the expertise
June 21, 2016
Dr. Christopher Joseph Devine, President Devine Guidance International
For the aerospace, defense, automotive, pharmaceutical or medical device industries, it really makes no difference when it comes to auditing the effectiveness of the quality management system (QMS): An established auditing program is a fundamental requirement. ISO 9001, ISO 13485, AS 9100, and the primary topic of most of Dr. D’s rants 21 CFR, Part 820 compliance, all have elements mandating that quality audits be performed. So the doctor always finds it quite disturbing when a device establishment fails to comprehend the importance of creating an audit schedule and actually performing the audits.
March 3, 2016
Linda Chatwin, Esq, RAC Manager Medical Regulatory Advisory Services, North America UL LLC
ISO had published the final draft of the latest ISO 13485 quality management standard for medical devices, and placed it out for voting on October 29, 2015. After a two-month approval voting period, the standard was approved for official publication. For background, once a standard has reached the Final Draft International Standard (FDIS) stage, comments and objections have been addressed, and only negative comments with well-reasoned, technical justification would be considered. Each technical reason is addressed in a comments resolution meeting, so that the parties resolve issues before the standard is published.
