BCS – Medical

Like any industry, the medical industry is also governed by government regulations and industry standards. ISO 13485 is one of the chiefs among these, especially in the medical sector.

ISO 13485 is the optimal device standard for the medical industry, ensuring that every medical device meets customer needs and relevant regulatory compliance laws. Our ISO 13485 consultants offer you a certification that helps keep customers and staff safe in hospitals, clinics, and similar medical settings.

ISO 13485 is built on the foundations of ISO 9001. It’s a standard that’s especially established for the manufacturing of medical devices. The main aim of ISO 13485 is to facilitate the regulatory requirements of a harmonized medical device.

If you choose this standard, BCS guarantee that you’ll mitigate legal and safety risks while developing a more economical workplace. Since ISO 13485 is a globally recognized standard for safety and quality for the manufacturing of medical devices, it can help businesses maintain a good reputation.

Why ISO 13485 is important for medical firms

Distributors, manufacturers, and designers stand to benefit from ISO 13485. For example, service providers and suppliers can use ISO 13485 certification to improve the marketability of their business as vendors continue to necessitate this certification.

During the manufacturing of medical devices, patient safety is dependent on the consistency and quality of medical products. Therefore, it’s important that the maintenance, control, and effectiveness of your quality management system is ensured since it directly affects users, patients, stakeholders, customers, and regulatory agencies.

ISO 13485 isn’t just valuable during implementation, its functionality extends to offering a thorough audit for testing a system’s effectiveness. It allows the manufacturer to confidently maintain and achieve compliance with regulatory requirements. In addition, ISO 13485 assists in mitigating failures and surprises that don’t just put a dent on the reputation of the manufacturer but affect patient safety negatively.