Building Your Bridge to the Island of ISO 13485:2016

Medical device companies have until March 1, 2019 to update their quality management systems to the ISO 13485:2016 standard. The simultaneous introduction of the Medical Device Single Audit Program and transitions to ISO 9001:2015 will leave manufacturers busy and certification bodies slammed. Therefore, it’s important to start the process now.

FDA Priorities: People, Simplicity and a Risk-Based Approach to Speed Time to Market

By utilizing a more straightforward methodology, FDA can free up and better use resources to focus on high-risk areas that have the biggest impact. "Simplicity requires that FDA remain limber," writes John Gagliardi. "For industry to be innovative, the federal government must be innovative as well."

Purchasing Controls: Draft the Best Supplier Quality Agreement

Quality agreements are an essential management tool to prevent supply chain problems. The best contracts clearly define the extent of control exercised over products, services, suppliers and sub-tier suppliers.

8 Design Control Issues Found During FDA Inspections

Involvement with numerous FDA inspections over the years has given me, I think, a unique perspective on design control trends—specifically, major design issues discovered during FDA inspections.

Resubmitting a 510(k) is More Than a Regulatory Decision

Do changes to your device warrant a 510(k) submission? There are several elements to consider: design controls compliance, risk analysis and postmarket surveillance data, among them.

Don’t Treat Your FDA Inspection Like an ISO Audit

Good Manufacturing Practices/QS Regulation and ISO 13485:2016 resemble each other with respect to medical device manufacturing and design quality systems. Despite the similarities, it is the interpretation and the approach of the investigator or the auditor that makes the experience very different. 

Device Recalls: Prepare for the Unexpected to Minimize Operational and Fiscal Damage

While no company expects to undergo a FDA recall, preparatory steps can decrease the costly and lengthy process of removing product from the market. Begin by knowing the leading causes of recalls.

CAPA Notes from an FDA Inspection

Corrective and Preventive Actions or CAPA touches nearly every process in the Quality Management System (QMS). Read insight gained by John Gagliardi while participating in the interactions between the inspector and the medical device manufacturer.

Medical Device Single Audit Program Attracts Growing Interest from U.S. Companies

While device manufacturers were slow to adopt the program in its pilot days, the initiative has gained traction since FDA named it an official program earlier in 2017.