Hard Work and Dedication Pay Off to Earn Recertification

At Cork Medical, maintaining the highest quality and regulatory standards is central to our commitment to deliver safe and effective medical devices. We are proud to announce that we have successfully renewed our Medical Device Single Audit Programs (MDSAP) certification alongside our ISO 13485 recertification.  

So, what are MDSAP and ISO 13485, and why does it matter? 

If you’ve ever wondered how companies ensure the safety and quality of medical devices, the answer often begins with a powerful standard: ISO 13485. 

• ISO 13485 is an internationally recognized standard that defines the requirements for a quality management system (QMS) specifically for the medical device industry. It provides a framework that helps companies consistently meet both customer expectations and regulatory requirements around the world. 

• MDSAP allows us to undergo one audit that satisfies regulatory requirements in multiple countries, including the USA and Canada. This single audit approach helps us streamline compliance while expanding our global reach.  

At its core, ISO 13485 is about ensuring that medical devices are safe, reliable, and effective. Whether it’s a simple thermometer or a complex implantable device, ISO 13485 helps guide every step of the product lifecycle, from design and development to manufacturing, distribution, and even post-market monitoring. 

By achieving and maintaining MDSAP and ISO 13485 certifications, companies demonstrate their commitment to quality, risk management, and continuous improvement. This builds trust with regulators, customers, and patients alike. 

Some of the key areas addressed by ISO 13485 include: 

• Risk management and product safety 

• Design and development processes 

• Manufacturing and process controls 

• Product traceability and documentation 

• Handling of customer feedback and complaints 

• Regulatory compliance and reporting 

To become ISO 13485 certified, a company must implement a compliant QMS and undergo a rigorous audit by a third-party certification body. Once certified, the company is subject to regular audits to ensure ongoing compliance and improvement. 

As a company operating in or supporting the medical device space, embracing ISO 13485 ensures we are meeting the highest standards of quality and safety. It opens doors to global markets, strengthens our operational processes, and most importantly, helps protect and improve our patients’ lives. 

Every person at Cork Medical plays a vital role in upholding our quality standards. Your dedication to following procedures and continuous improvement makes achievements like these possible. Once again, congratulations to our Cork team on this remarkable achievement!