Bellus Medical recently earned the ISO 13485:2016 certification and leads the industry with this important designation. It’s the best internationally-accepted model a medical device provider can implement to demonstrate compliance to laws and regulations of the medical device industry. Bellus is the first microneedling company to earn this designation!
We sat down with Joe Proctor, Bellus Medical President and CEO, to learn more the ISO 13485:2016 certification, take a look!
Benefits
With the ISO 13485:2016 certification, Bellus Medical is able to:
- Get to market faster with new products.
- Improve customer and patient satisfaction by providing medical devices and related services that consistently meet needs while maintaining applicable regulatory requirements.
- Enhance trust by focusing on quality at every level of the organization … product, people and processes.
- Secure global business because the standards meet most international regulatory agencies.
Requirements
- An organization must document internal auditing procedures, non-conformance controls, preventative and corrective actions, process and design controls, record retention, accountability and traceability.
- A risk management system must be thoroughly conducted and documented throughout a product’s entire lifecycle, from initial concept to delivery and post-delivery.
