ISO13485
Quality & certifications
ISO 13485:2016 certification
Medical Moulded Products operates a medical device quality management system certified to ISO 13485:2016 by CQS. This standard focuses on meeting customer and applicable regulatory requirements for medical devices and related services.
Our certificate
Our certification covers the cleanroom manufacture of plastic moulded medical devices and associated products.
View ISO 13485 certificate (PDF)Opens in a new tab. Refer to the certificate for the full scope and terms.
- Certification body
- CQS (Certified Quality Systems) Ltd
- Certificate number
- MD1348554
- Original approval
- 12 February 2019
- Certificate expiry date
- 17 March 2029
Quality management for medical manufacturing
For your engineering, procurement and quality teams, our certificate provides a clear reference during supplier qualification. Discuss your component specification, inspection needs, traceability and documentation requirements with us so these can be agreed as part of your project.
ISO 13485 certification relates to our quality management system and its stated scope. It does not itself provide product approval or confirm that a component is sterile.
Let’s review your requirements
Need certification information for supplier approval, or want to discuss a component? Contact our team.