The process of validating medical devices is essential to ensuring that each one is safe for patient use and will work in the way it was intended to. Quality and validation are vital to ensure the device will function correctly without room for error and potential to harm.

Process validation examines every step of the manufacturing process, including the implementation of a quality management system. Design validation focuses on the construction of the device.

What do you need to be compliant?

Everything needs to be tested, and the results must be recorded during the validation process. All the components of the device and how they are put together must be of the same quality and consistently work as they’re supposed to.

Manufacturers need to have an established Quality Management System in place in order to sell within the EU.

Our team is committed to helping you get safe and effective products to market in line with your business goals. CLIN-r+ understands that validation involves more than explaining a process outcome. We help you ensure documentation meets regulatory requirements and advise on sustainable processes to set you up for ongoing success. Because we tailor what we do to each client, we understand the support you need, create tailored strategies, and plans and can assist when there are changes and developments.

How can Clin-r+ help?

CLIN-r+ converts your GSPR checklist to a Validation Master Plan and matches suitable Common and Harmonised Standards to demonstrate conformity. We also identify the verification testing needs for your Master Validation Plan.

We create biocompatibility plans and, if needed, project manage your biocompatibility evaluation requirements. Then creating biocompatibility reports which report findings that can be understood.

CLIN-r+ supports clients to create post market systems that are linked to your Risk Management and complaints process to management your devices’ lifecycle and generate PSURs.

We also provide services such as mapping your Economic Operators and creating compliant Service Level Agreements or providing templates for you to do this.

Need more details?

We are here to assist. Contact us, set up a meeting, join our mailing list or follow us on LinkedIn.

You can also check out these white papers on our MedTech Academy:

• Clinical Development Plans (CDP)
• EU MDR Readiness Checklist
• Clinical Investigations for Medical Devices and IVD
• Biocompatibility
• Risk Management