Medical Device Quality Services

In the blog

FDA commissions review of the 510(k) process
Very interested to read recently that the FDA has commissioned the US Institute of Medicine (IOM) to review the 510(k) process. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183497.htm Whilst the review isn’t due to be complete until March 2011 I’ve already seen several articles from industry associations defending the current process. As part of the IOM there will be two public [...]
BSI acquires German Notified Body
BSI has acquired German based Notified Body EUROCAT. EUROCAT is accredited for the certification of devices, IVD’s and active implantable’s and also offers product testing. See the official BSI press release here .
BSI adds to Fast Track service offering
BSI has added a new accelerated programme for device manufacturers (CE-Dedicated Fast Track) looking to bring their product to market quickly.
CE-Dedicated FastTrack offers reviews within 45 working days or less and does this by dedicating a reviewer to the project and by performing the review off-site. This is the 4th such initiative BSI have introduced [...]

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Quality

Does your current quality system allow you to sell products in the US?
Do you need someone to undertake an independent audit?
Do you need assistance with supplier audits?
Does the design company and contract manufacturer you are working with have the appropriate quality system certification?

The UK office of Emergo Group (formerly Mediqol) has practical hands on experience of working with medical device and IVD manufacturers from around the globe to implement and maintain compliant quality systems. All our quality consultants are from a medical device background and have experience of managing quality systems.

We have significant experience of preparing fully customized quality management systems that comply with the requirements of FDA Quality System Regulation (FDA QSR) and ISO 13485:2003 which is a quality management system designed specifically for medical device companies. ISO 13485:2003 overlaps with ISO9001:2000 in many areas but demands additional requirements for design and process control, accountability, traceability and more. In addition we can prepare systems that are also compliant with Canadian, Australian and Japanese quality requirements.