5 Lessons I Learned from a Successful ISO 9001:2015 Certification Audit

Effective risk management requires an  in-depth and sometimes painfully honest assessment  of your processes and your areas of risk.  by Lil...

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...

Why Every Business Needs to Make ISO Certification a Priority in 2015/2016

ISO certification may be challenging  to attain but offers many benefits. by Stuart Patch   Content Writer, Compass Assurance Services info...

MFG DAY 2015: U.S. Manufacturing at a Glance

In preparation for Manufacturing Day 2015, U.S. manufacturing facts and figures by David R. Butcher, Marketing Communications, MasterControl...

4 Reasons Why Document Review is Crucial to Compliance

When was the last time you reviewed  your quality documents? by Cindy Fazzi Editor, MasterControl Insider When was the last time you reviewe...

MasterControl Revs Up Improvement

MasterControl call its Lean Six Sigma efforts the  “Green Line Operational Excellence” program (GLOE). by Craig Gygi Executive VP Operations...

Four Reasons to Automate SOP Management in FDA and ISO Environments

In FDA and ISO environments,there are multiple  reasons to consider automating SOP management. by David R. Butcher,  Marketing Communication...

6 Ways to Ensure Your QMS Meets FDA and ISO Compliance

Optimizing their QMS will help companies  in  FDA  and ISO  environments realize maximum value  in their compliance efforts . by David R. Bu...

Setting an Organization's Risk Management Context

There are five fundamental questions  you need answered to manage risk by Rod Farrar Director, Paladin Risk Management Services There is con...

Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices

FDA issued a new draft guidance in 2013 on  the biological evaluation of medical devices.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...