Safety and Quality FDA Regulations Posts

Time For SaaS?

Time For SaaS?

Michael Reynolds

Outsourced Enterprise Compliance and Quality Management  — application and data management in the form of Software as a Service (SaaS) — is a partnership needed more  today than ever, particularly in the increasingly complex regulatory environment that Pharma, Biotech and Medical Device companies find themselves. (more…)

Q&A with Bill McLain on Internal Audits

Q&A with Bill McLain on Internal Audits

Mark Crawford

Bill McLain is an American Society on Quality (www.asq.org) expert on auditing. He is a member of Regulatory Affairs Professional Society (RAPS) and ASQ’s Biomedical Division. McLain has earned the Regulatory Affairs Certification and holds a Bachelor of Science degree in mechanical engineering from Grove City College. (more…)

The Increasing Need for Quality Medical Devices is Matched by the Need for Compliance with ISO 13485:2003

In October 2010, Medtronic agreed to pay $268 million to settle U.S. lawsuits and claims related to its Sprint Fidelis family of defibrillation leads recalled three years ago due to faulty wires. In 2009, the company estimated that at least 13 people may have died because of the problem. It’s situations such as this that emphasizes why standards have been put in place, such as ISO 13485: 2003, that help medical device companies maintain quality assurance and manage risk. (more…)