Quality & Compliance in Medical Device Manufacturing
Did you know that in the world of medical devices, ‘winging it’ is not an acceptable quality control strategy? Here at Prevailing Medical, we take our quality and compliance as seriously as a surgeon prepping for surgery!
We are dedicated to maintaining the highest standards of quality and compliance throughout our manufacturing processes, ensuring that our products meet both industry regulations and the needs of our clients.
The Importance of Quality Assurance
Quality assurance protocols are essential for safety in medical device manufacturing. At Prevailing Medical, our commitment to quality assurance enhances our company’s reputation and builds customer trust. We are proud to be ISO 13485:2016 certified, demonstrating our adherence to internationally recognized quality management standards. Additionally, our cleanroom certification ensures that our manufacturing processes meet the highest standards for safety.
Cleanroom Standards and Practices
Cleanroom classifications are vital in medical device manufacturing, with levels ranging from ISO Class 1 to ISO Class 9, each designed to minimize contamination risks. Prevailing Medical operates an ISO Class 7 cleanroom, ISO Class 7 gowning room, and ISO Class 7 packaging room, ensuring strict controls that enhance product safety and reliability. We also utilize an ISO Class 8 cleanroom for additional processes.
Validation and Verification
We prioritize process validation to ensure that our manufacturing processes consistently produce high-quality products. For a deeper understanding of our processes, explore our "Guide to the Catheter Development Process." or visit our concept and development page!
Certification and Audits
Achieving certification, such as ISO 13485:2016, is crucial for medical device manufacturing, as it demonstrates compliance with international quality management standards. At Prevailing Medical, we undergo rigorous internal and external audits to maintain this certification and ensure ongoing compliance with regulatory requirements.
That's a Wrap!
Our unwavering commitment to quality and regulatory compliance is at the core of Prevailing Medical, alongside our dedication to upholding high standards of customer relations.
By adhering to ISO 13485:2016 standards and implementing rigorous validation processes, we ensure that our products meet the highest quality benchmarks. By prioritizing quality assurance and fostering transparent communication with our clients, we build lasting relationships founded on trust and reliability.
