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Medical Devices | quality systems | News | iso 13485 | R&Q | Minnesota

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.
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quality systems | submissions | guidance documents | good manufacturing practices | FDA | biological product | current good manufacturing practices | combination product | Combination Products

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
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quality systems | production quality | design quality | China | FDA | medical device | regulatory | quality

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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