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News, FDA, 510(k) submission, regulatory news, compliance, 510(k)

What You Should Do About the Two New FDA Draft Guidance Documents

It has been a long journey for the FDA to get the new draft guidances..

FDA, compliance, UDI, massmedic

MassMEDIC Webinar: A Whole New World of UDI - May ...

If you missed R&Q's Paul Robinson discuss UDI during R&Q's afternoon workshop..

FDA, compliance, advamed

AdvaMed Webinar: Avoiding and Managing FDA ...

Did you miss former FDAer Jake O'Donnell speak about avoiding and managing FDA..

inspection, fda inspection, FDA, white paper, compliance

NEW White Paper - Practical Considerations for ...

There’s a formula for effectively managing an adverse FDA inspection and the..

IVD, compliance, UDI, Boston, IVDR, BIOMEDevice, Workshops

R&Q's Can't-Miss Education Event of the Year: An ...

Those in the northeast, get ready! Not only will R&Q be exhibiting at this..

india, labeling, medical device industry, medical device, compliance, regulatory, registration

India Medical Device Labeling

This week I will provide some information about labeling in India. CDSCO..

internal auditor, quality system procedures, quality procedures, compliance, internal audits

Internal Audits, the After-Thought of a Quality ...

Why is it that Internal Audits are forgotten, or even worse feared? Why is it..

Medical Devices, visual signal, risk level, alarm systems, safety feature, compliance

Auto Compliance

Coming to your commercial break at the 2014 Super Bowl at Met-Life Stadium -..

internal auditor, auditee, external auditor, compliance, observation, Preventive Action, internal audits, corrective action

Thoughts About Auditing

'Tis the season for auditing. The beginning of this year, just like years in..

medical device, compliance, standard

Keeping up with Standards

With recent clients I have been dealing more and more with new standards coming..