WHO Launches MeDevIS: A Medical Device Global Innovation
The World Health Organization (WHO) has introduced a groundbreaking global database of medical devices known as MeDevIS (Medical Devices Information System). This innovative platform boasts a comprehensive list of 2,301 medical devices, covering a broad spectrum of treatments and diagnoses—from neonatal care to cardiovascular disease. Centralizing Critical Information for Global Stakeholders MeDevIS aims to revolutionize […]
New Advances in Organ Transplantation
Organ transplantation stands as a sign of hope for those battling organ failure, yet the chance of rejection continues to haunt the success of these life-saving procedures. Daniel Pavicic Meier, an experienced pharmaceutical consultant, recently shared a LinkedIn post highlighting a new therapy that proves effective against kidney transplant failures. Our Practice Lead, Teresa Gorecki, […]
Navigating the Modernization of Cosmetics Regulation Act of 2022: A Decade of Evolution and Industry Impact
New requirements for cosmetic product manufacturers under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) are being phased in throughout 2024, affecting cosmetics products and facilities. That means cosmetics manufacturers must analyze their quality systems to identify gaps and ensure they are ready to implement any necessary changes to comply with the new law. […]
Navigating the Future of CAR T Cell Therapy Development: Insights from FDA Guidance
Cell and gene therapies represent a new medical frontier, offering hope for treating rare, orphan, and challenging diseases. However, the journey from development to market approval for these personalized medicines is intricate and multifaceted. With this new medical frontier, it is vital that we properly navigate the future of CAR T Cell Therapy and the […]
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 […]
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 […]
Regulatory Reform: US Election’s Impact on FDA Enforcement
The election of Donald Trump as President-Elect of the United States was, and continues to be, a watershed moment in the 200+ year American experiment. The public, the business community, and government are all currently adjusting to a new, unanticipated reality. A veritable frenzy of journalistic speculation is attempting to analyze the messaging of the past, […]
