Quality Management Systems and Regulatory Compliance
Post-Market Surveillance Compliance
Acting QA/RA Manager
Acting Legal Manufacturer
Without Regulatory Compliance, there is no route to market for medical devices. Regulatory Compliance is achieved through compliance with Quality Management Systems (QMS).
Vestech Medical’s parent company, Cryptych, operates on an established and tested QMS. Our QMS is:
- ISO 13485:2016 certified
- 21 CFR Part 820 (US QMS regulations) compliant
- EU Medical Device Regulations (MDR) compliant
- AU TGA Medical Device Regulations complaint
- MDSAP compliant – QMS that satisfies requirements of multiple regulatory jurisdictions (US, Canada, Brazil, Japan, and Australia regulations)
Vestech Medical offers a bespoke QMS that meets the regulatory requirements unique for your device. We will provide you QMS training to support you in the implementation and ongoing management of your QMS.
Once your product is approved by a regulatory authority, Post-Market Surveillance (PMS) activity is required on an ongoing basis. The main goals of PMS are:
- Systematically identify risks during practical usage
- Monitor product performance in the field
- Detect product faults and safety issues
- Quickly initiate necessary measures, such as recalls
- Constantly reassess the benefit-risk of the device
- Identify opportunities for device improvement
The PMS requirements differ for each jurisdiction. We will support you to ensure that you remain compliant to your relevant regulations in the post-market stage of your device lifecycle.
The QA/RA Manager is the responsible for the implementation and continued compliance of the Quality Management System (QMS) and Regulatory Affairs. Evidently, such a role benefits from extensive experience, and is in-fact mandated by the EU Medical Device Regulations (EU MDR) to meet a minimum level of competency.
This can be a challenging role to fill for micro or small companies, especially start-ups. Vestech Medical has staff that are experienced QA/RA professionals and can provide the role of QA/RA Manager for your organisation. It will give you the confidence that your company will comply with QMS as stipulated by the regulations.
It takes a proverbial village to design, manufacture and obtain approval for a medical device, but one organisation must assume responsibility for the product’s design, manufacture and post market surveillance. In regulatory speak they are the “Legal Manufacturer”, and they are the legal identity that is audited by the regulatory agencies during the initial regulatory submission and once the product is on the market. The regulatory agencies not only audit the technical file, but also the Quality Management System (QMS) to ensure that you have procedures covering all aspects of ISO 13485 and any jurisdiction specific requirements. The audits will also verify that the product development was conducted in a manner compliant to the QMS. Therefore, the QMS needs to be implemented and functioning before generating the technical documentation required for regulatory approval. This can be a daunting and overwhelming proposition for anyone, but particularly for small organisations and start-ups concentrating on perfecting their technology and their product.
The legal manufacturer must possess a QMS, which is a substantial time and cost investment for small organisations and start-ups to set up from scratch. Vestech Medical already operates a QMS certified to ISO 13485:2016 and 21 CFR Part 820 which can be adapted to your product’s needs. Product development can be done under the umbrella of Vestech Medical’s QMS so the generated technical documentation can be used for regulatory submission.
Importantly, Vestech Medical will not leave you behind in this process. We will work closely with you through to regulatory approval and beyond as needed. Providing you education, exposure and first-hand experience is part of our service. If and when you feel you are ready to be passed the legal manufacturer baton, Vestech Medical can work with you to transfer the product to your organisation.