The medical device and diagnostic industry is at the forefront of innovation, dealing with accelerated product development, digital convergence, and globally aligned regulations. From EU MDR and FDA’s ISO 13485 alignment to MDSAP, GUDID, cybersecurity, and VSMR, companies must navigate an intricate regulatory landscape.
At Compliance Architects, we bring expert support to medical device manufacturers, ensuring compliance, reducing risk, and fostering innovation to improve patient outcomes.
Our expert consultants offer a full suite of services to help medical device and diagnostic companies thrive in a highly regulated industry.
Our tailored solutions empower medical device and diagnostic companies to:
With Compliance Architects, you gain a trusted partner for navigating the complexities of the medical device industry while staying focused on innovation and patient care.
At Compliance Architects, our leadership team combines decades of hands-on experience and strategic insight. From plant-floor operations to C-suite leadership, we’ve helped the most respected companies in the medical device and diagnostics sectors address their most complex challenges.
With over 30 years of experience, John has worked with all classes of medical devices across the globe, from startups to global corporations. His expertise spans combination products, in-vitro diagnostics, and resolving regulatory challenges, including corporate warning letters and probation agreements.
Pedro’s career spans chemical engineering, pharmaceuticals, and medical devices, with a focus on global manufacturing and innovative surgical technologies. He has extensive experience in developing minimally invasive solutions and establishing state-of-the-art manufacturing facilities.
With over 30 years of experience, Teresa specializes in quality assurance and compliance for medical devices and diagnostics. She has led numerous FDA approvals and developed risk-based quality systems tailored to clinical development and regulatory success.
Given the pace of innovation in the medical device industry and device design,...
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In my previous article, EU MDR Implementation: Important Dates and Challenges, we examined...
Navigate the complexities of medical device compliance and innovation with expert guidance. Compliance Architects provides tailored solutions to meet your regulatory and quality challenges head-on.
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