Collocco Consultancy
Reach for Compliance
Carrying you from confusion to compliance
Small inefficiencies in file management can cause huge delays in bringing a medical device to market. We know how complicated and overwhelming compliance can be and how costly regulatory errors are.
Here at Collocco Consultancy, we support our clients to become compliant by setting up and refining efficient Quality Management Systems and processes.
We are a friendly, dedicated team of Quality, Compliance and Regulatory professionals providing support with; Quality Management Systems, Audit Support, Sterilisation, Biocompatibility, Clinical Evaluation, Post Market Surveillance and Risk Management reviews to name a few.
We also offer Technical File support; Gap Assessments, remediation and/or generation of Technical Files such as; CE, UKCA marking and global registrations support for the medical and life sciences industries.
Your Expert Team
We are a proud Welsh company founded in 2018 by Jill Rosser. Between us, we have over 40 years combined hands-on experience in the Quality, Compliance and Regulatory profession. We understand how frustrating it can be to implement changes in a timely cost effective manner.
Having been involved in the full product life cycle for many years we can quickly navigate your systems to make sure your products are compliant. Compliance supports the safety and effectiveness of a product and in turn builds trust with your customers and better supports patient benefit.
How we can support you…
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Quality Management Systems
If you are looking to implement a Quality Management system or require scope extension or assistance with remediation, we can help. We have experience in writing many Quality Management systems to: ISO9001, ISO13485 including MDSAP countries for example. We can tailor your Quality Management System for your specific needs.
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Medical Device and Technical Files
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 and can help you navigate the pathway.
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Training
Make sure your team has the skills needed to understand and comply with the most recent changes to regulations with one of our training courses. We understand how time consuming this can be. We can offer flexible solutions with an aim to minimise disruption.
Not sure where to start?
Reach out to a member of our team today so we can help you find the best options to suit your needs.
Systems that are running smoothly...
“Working with Jill at Collocco Consultancy was a pleasure. Amending the Quality Management System at Huntleigh Healthcare ltd to accommodate the Medical Device regulation 2017/745, delivering training and assisting with Technical files updates was never going to be an easy task and with Jill's help on this matter made the transition seem relatively easy”.
– Steve Monks, Director QRE Compliance, Huntleigh Healthcare Ltd.
