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Exclusive Insight: How FDA Reshapes Medical Device Quality Guidelines with ISO 31485-2016

ISO 31485-2016 Exclusive Insight: How FDA Reshapes Medical Device Quality Guidelines

The highly anticipated FDA Decision on the Harmonization of the Medical Device Quality System Regulations with ISO 31485-2016 has been released, marking a significant development for the industry. Here are the key highlights and insights into the Final Proposed Rule of the ISO 31485-2016 harmonization. Highlights of the Proposed Rule Two-Year Compliance Period Industry stakeholders […]

RIC Inaugural Annual Meeting: Proud & Excited to be a Silver Sponsor!

Compliance Architects is proud to be Silver Sponsor of this year’s RIC inaugural annual meeting! Our team will be attending the event March 22-23 at Covene in Arlington, VA. We can’t wait to meet you! RIC Inaugural Annual Meeting Details The REMS Industry Consortium fosters collaboration and innovation to advance patient safety, appropriate access, and […]

life sciences staffing

Current Talent Trends, and Industry Needs in the Next 5-10 Years

The following transcript is taken from a PMWS interview with Compliance Architects CEO Jack Garvey. Jack discusses the current talent trends and what he thinks the industry will need in the next 5-10 years. Watch the full interview discussing talent trends and industry need here: 2022 PMWS by Executive Platforms Talent Trends- The Crisis The […]

Essentials of Post-Inspection Actions: From FDA Notices to Criminal Prosecution | August 18, 2022 | 2:00–3:30 PM ET | Live Webinar | FDLI

Attention life science quality and compliance professionals. Mark your calendars for this Thursday, August 18th at 2PM ET! Our colleague Teresa Gorecki is presenting with four other outstanding experts on the Essentials of Post-Inspection Actions: From FDA Notices to Criminal Prosecution. This program is part of FDLI’s Summer Learning Series, and will be an exceptionally important […]

Randy Lumia

Welcome Randy Lumia, SPHR, SHRM-SCP to Compliance Architects®

It gives us great pleasure to announce that Randy Lumia has joined us as a full-time Vice President of Human Resources & Organizational Effectiveness.  As many of you may already know, Randy Lumia has been supporting us for about a year assisting with HR and talent matters. During this period, we have continued to bring Randy […]

John (Jack) Garvey Has Been Selected by Our Partners QbDVision to Join Their Newly Formed Board of Advisors

We are excited to announce that our CEO, Jack Garvey, has been selected by our partners QbDVision to join their newly formed board of advisors! Check out the LinkedIn excerpt below to learn more. LinkedIn Post QbDVision Taken from LinkedIn… “At QbDVision, we firmly believe that finding the right guides is just as important as […]