The modern medical device industry has transformed global healthcare for one single reason: new technologies enable more accurate diagnoses. However, to be effective, every part that goes into a medical device must be of the highest, fully functional, quality to help ensure patients ultimately receive the right treatment for their concerns. To participate in the quality conversations and considerations for the medical device industry, our Business Development Manager Europe, Stephen Moglia, represented Pro QC at the Medical Device & Diagnostic Quality Assurance Conference held on 30 & 31 March 2022, at the Sheraton Brussels Airport Hotel in Belgium. The Covid-19 pandemic highlighted just how important quality is, with the consequences of device failure so much more severe. Massive supply disruptions have led to increasing pressure on suppliers to manufacture final products with limited parts availability while continuing to meet high-quality standards. Discussions at the conference revolved around the regulatory and quality considerations following the amendments in the supplier quality prerequisites mentioned in ISO 13485, key documented EU MDR and IVDR requirements, and the Medical Device Single Audit Program (MDSAP). This has refocused on a risk-based approach to how quality expectations can be managed in a step-by-step process. Innovation arose as a key means to enable better compliance. Solutions were offered, including using technology to further monitor and collaborate with suppliers, for example, through increasing virtual supplier audits, as well as the use of technology to develop fresh supplier quality training programs. The Medical Device & Diagnostic Quality Assurance Conference also highlighted how cost efficiencies could be achieved while maintaining high regulatory quality standards for international markets, despite complex supply chain solutions. Pro QC looks forward to remaining a part of the conversation in bringing you the best strategies for high-quality control in your supplier management systems. Stephen Moglia, Business Development Manager Europe About Us Pro QC is a Global Quality Assurance company with close to 40 years of experience in the Medical Devices industry. Our range of solutions covers the full spectrum of quality assurance. We provide medical device inspections, supplier verifications, ISO 9001 audits, ISO 13485 audits, SA8000 audits, PPAP audits, and more. Contact us at info@proqc.com
