R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

Webinar Q&A: Risk-Based Approach to ISO 13485:2016

Last month and as part of the R&Q Intelligence Series we conducted the webinar, Risk-Based Approach to ISO 13485:2016: Risk considerations and implementation. Risk considerations and implementation of a risk-based approach in your QMS processes is one of the most significant changes to the current version of ISO 13485. Medical device organizations must define how they manage risk in their processes and how the risk of one process affects other risk aspects of the QMS.

At the end of the webinar we answered several questions, and a sampling of those questions and answers is below. To read more about the webinar, read all questions and answers from the session, and gain access to the slides and recording, check out the on-demand webinar.

Minnesota Momentum: R&Q Hires Member of ISO Technical Committee 210, Mark Swanson

Mark Swanson is R&Q's new Director of Minneapolis–Saint Paul (MSP) Territory. Welcome, Mark!

Mark's addition firmly establishes R&Q in the Twin Cities and prepares R&Q to handle growth in the region. The hiring also builds upon R&Q's existing technical leadership, increasing company-wide capability. Mark will certainly be seen and heard across Minnesota on behalf of R&Q, starting today at MD&M Minneapolis!

Mark is a Senior Member of ASQ and holds ASQ certifications as a Certified Biomedical Auditor (CBA), Certified Quality Engineer (CQE) and Certified Manager of Quality/Organizational Excellence (CMQ/OE).

Read on as we ask Mark three questions about his work on the ISO Technical Committee and shed light on his background/experience.

Would you like fries with your Combo meal?

On January 18, 2013, the FDA announced their final rule on current good manufacturing practices for Combination products. These Guidance Documents will tell companies when submissions would be required for any post-approval changes to a combination product.
First off, what are Combination products you may ask? It is any combination of a drug, a device, or a biological product. As defined in 21 CFR 3.2, this may refer to two or more regulated components that are physically or chemically combined into a “single” entity, or even a “kit” combination where the before-mentioned are packaged together in a single package.
The Combination Products Coalition (CPC) sees this as an excellent move by the FDA, and hopes it will reduce the amount of duplicated work for drug, device, and biological product requirements.
But with the new Combination policies, how will this affect current manufacturers? A big long term “pro” might lead to a short term “con” as companies will need to modify their current Quality Systems to accommodate this new rule. Also, what will this do to the number of combination product filings? Will companies take this as a positive, or see it as an additional hurdle?
-SJG

International Spotlight - China

When people ask my opinion of the most difficult country to register medical devices internationally, I would have to say it is China. China is considered to be an “emerging market”- it is getting more and more lucrative to register there as the population gets larger and wealthier. China accounts for 1/5 of the world’s population – about 1.3 billion people. Most marketing departments feel that this huge market is worth the incredible effort that it takes to register medical devices. China registration is therefore usually in the international registration strategies for most large medical device companies.

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