ISO 13485:2016 What are the Changes About?

The 2016 version of ISO 13485 was published  in February 2016. Become familiar with  the standard's  changes so your  products stay on t...

When Is A CRO Not A CRO? (And why does that make enforcement hard?)

  It looks like a CRO. It sounds like a CRO. But is it really a CRO? by Jamie Colgin Colgin Consulting What do the following types of compan...

New Developments in IEC 60601 Amendment 1 & Risk Management: Part 2

Medical manufacturers live in a world where  regulatory compliance must always be considered,  including changes associated with IEC 60601. ...

New Developments in IEC 60601 Amendment 1 & Risk Management: Part I

Risk management monitoring of production and post-production performance is critical  to help ensure safe and effective devices  in the mark...

Preparing for ISO 13485:2016 Changes

by James Jardine, Marketing Communications, MasterControl As 2015 comes to a close, medical device manufacturers throughout the world share ...

How ISO 9001:2015 May Preview Upcoming ISO 13485 Changes

ISO 9001:2015 can help medical device  companies anticipate forthcoming  ISO 13485 changes. by David R. Butcher Marketing Communications, Ma...

Three Keys to Successful FDA Inspections – Preparation, Management and Follow Up

Preparing for an inspection will help ensure a smoother,  less stressful experience. A mock inspection is a useful practice tool. by Kelly T...

7 Ways to Reduce Human Error on the Drug and Device Manufacturing Floors

Human error is responsible for more than  80 percent of failures and defects.  by Ginette Colazzo President of Ginette M. Collazo, Inc. Huma...

The Bright Future of Quality and Compliance

Quality and compliance are  standing at a crossroads. by Craig Gygi Executive Vice President, Operations MasterControl Quality and complianc...

The ISO 9001:2015 Change Train is Gathering Steam

Big changes are coming to ISO 9001.   Prepare to jump on this change train! by Robyn Barnes Marketing Communications, MasterControl ISO chan...

The Perks of Pursuing a Career in Quality Management

Don't fear the auditor!  Instead, become one!  Auditing can  lead to a variety of career paths in an organization. by Greg Peckford Foun...

Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices

FDA issued a new draft guidance in 2013 on  the biological evaluation of medical devices. by Cheryl Wagoner Principal Consultant/Owner Wagon...