Medical Device and Technical Files
Are you struggling to know where to start with your medical device and technical files?
Is your file management stopping you from being compliant?
Is it preventing you from bringing your product to market in the first place?
Whether you’re completing Design History Files, Product Summary Files or Medical Device Technical Files for the first time, or are struggling with file remediation or maintenance we are here to help. We have extensive experience with working directly with various Notified Bodies.
We can help you:
Technical file generation and ongoing maintenance to give you confidence that your devices remain compliant.
Gap analysis and technical file remediation in line with UK Medical Device Regulation, EU Regulations 2017/745 and 2017/746.
Generation of risk management, design and development documentation to support your QMS requirements.
Clinical evaluation plan and reports to ensure your Medical Devices comply with Regulation (MDR) 2017/745 / (IVDR 2017/746) so that they can be sold in Europe. This is also an essential step in applying for CE and UKCA marking.
Post market surveillance plans and reports to give your customers confidence in the safety and effectiveness of your device.
Labelling and IFU support for assessments with your notified or approved body.
Generation and support for worldwide market registrations to continue to reach all the people who will benefit from your medical device.
Get in touch with us today at reach@colloccoconsultancy.com to arrange your free, no-obligation consultation session.
Systems that are running smoothly
“Jillian and her team were able to provide clear and concise action plans, explain the requirements and present solutions to close the gaps. To work within our agreed upon budget, I was very impressed. Over the years, I have dealt with many consultants, and I can attest that Jillian displayed a level of professionalism that is seldom matched. It has been a pleasure to have worked with Jillian….”
-Denise Lane – QA/RA Manager, LaproSurge Ltd.
Find out more about how we helped Denise and her team update their Quality Management System and various technical files in order to comply with Medical Device Regulation 2017/745.
Our Other Services
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Quality Management Systems
What should we know about the services you provide? Better descriptions result in more sales.
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Training
What should we know about the services you provide? Better descriptions result in more sales.