Medical device manufacturing requires an unwavering commitment to quality – most importantly to ensure patient safety, but also to maintain compliance with stringent regulatory standards. Hobbs Medical exemplifies this dedication to quality and reflects that quality-first approach through its adherence to internationally recognized certifications, notably ISO 13485 and the Medical Device Single Audit Program (MDSAP).
ISO 13485 and MDSAP
ISO 13485 is an international standard for the medical device industry that specifies requirements for a quality management system. It ensures that organizations consistently design, develop, produce, and deliver medical devices that meet regulatory and customer requirements. Hobbs Medical has held ISO 13485 certification since 2002.
The Medical Device Single Audit Program (MDSAP) enables manufacturers to demonstrate their quality management system compliance to ISO 13485 standards, in addition to the medical device regulatory requirements of several international medical device regulatory authorities, including the United States and Canada. Hobbs has held MDSAP certification since 2020.
The Importance of Certifications
For Hobbs Medical, maintaining ISO 13485 and MDSAP certifications is more than a regulatory formality; it’s a testament to our unwavering commitment to quality and excellence. These certifications signal to our customers that we adhere to the highest standards in medical device manufacturing, ensuring the safety, reliability, and efficacy of our products.
However, we also know that certifications are not the endgame. Quality is not a one-time achievement but an ongoing journey. In the Today’s Medical Development article The cost of non-compliance in MedTech, author Oliver Eikenberg stated it clearly, “fostering a culture of compliance is essential for long-term success.”
At Hobbs Medical, we continually assess and enhance our processes to align with the highest expectations of our customers and our own dedication to designing and manufacturing the highest quality products. Our ISO 13485 and MDSAP certifications simply reflect this dedication.
Find out more about what Hobbs Medical can do for you, reach out to our team today.
