Collocco Consultancy
Reach for Compliance
Compliance Simplified. Success Amplified.
At Collocco Consultancy, we help medical and life science companies achieve and maintain compliance through efficient, scalable and audit ready solutions
Our Core Services
We support clients across the full product lifecycle with tailored, audit-ready expertise in:
Full Project Management; strategy planning, governance frameworks and end to end delivery oversight to keep complex programmes on track
Quality Management Systems (QMS); Setup, refinement, optimisation and continuous improvement of compliant QMS structures
Audit Support; Preparation, readiness assessments, audit support and post audit remediation to strengthen compliance and reduce risk
Design & Development; Guidance across concept, prototyping, verification, validation and design transfer
Sterilisation & Biocompatibility; Technical support, documentation and alignment with regulatory and standards requirements
Clinical Evaluation & Post-Market Surveillance; Planning, reporting, evidence appraisal and lifecycle alignment
Risk Management Reviews; Generation/gap analysis, remediation and integration of ISO14971 aligned risk processes
Identification; Labelling, UDI & Registration; Generation/gap analysis, remediation and implementation of compliant identification and traceability systems
Technical File & Regulatory Support
We provide end to end support for technical documentation, regulatory submissions and global market access, including:
Generation/Gap Assessments & Remediation; Generation or comprehensive reviews of existing documentation and targeted corrective actions to achieve compliance via actionable plans
Global Regulatory Strategy; Strategic regulatory planning for medical devices, IVDs, and combination products across EU, UK, US and international markets
Technical File Generation; Creation, refinement and maintenance of CE marking, UKCA and international submission packages.
PRRC - (MDR/IVDR); Acting as or supporting the Person Responsible for Regulatory compliance ensuring continuous regulatory alignment
UK Responsible Person - (UKRP); UKRP services, including registration, liaison with MHRA and oversight of UK market compliance
Why Clients Choose Us
Agile & Scalable; Our extended consultant network allows us to flex with your needs
Deep Expertise; We bring decades of real-world experience across multiple regulatory systems and submissions. IRCA Lead auditors in ISO13485(inc. MDSAP) and IRCA Pharmaceutical cGMP.
Outcome Focused; We deliver practical, compliant solutions that support patient safety and business growth
Whether you are implementing a quality management system or launching a new product, preparing for an audit, or navigating complex regulatory requirements, we are here to help you move forward with clarity and confidence
A Network of Excellence
Founded in 2018 by Jill Rosser, we are a proud Welsh consultancy service with over 40 years of hands on experience in Quality, Compliance and Regulatory Affairs. We under stand the pressures clients face; being tight timelines, evolving regulations and the need for cost effective solutions that do not compromise on quality or safety.
What sets us apart is our agile model. In addition to our core team, we collaborate with a trusted network of experienced consultants who bring specialist expertise across the full product lifecycle. This allows us to scale quickly, respond to complex challenges and deliver tailored, high impact solutions.
Whether you are navigating a regulatory transition, preparing for an audit, or launching a new product. We have supported many clients across the full product lifecycle, from concept to market and beyond. Our deep industry knowledge means we can quickly assess your needs, systems, identify gaps and implement practical, compliant solutions that align with your requirements.
Compliance is not just about ticking boxes, it is about ensuring product safety, building customer trust and ultimately improving patient outcomes.
That is why our clients rely on use to delivery clarity, confidence and results.
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 and let us start the conversation flowing, your free session is just a click away
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”.
Director QRE Compliance, Huntleigh Healthcare Ltd.
See our client success stories
We love working with our clients, helping to transform their businesses. Our success stories take you through a case study of the work we’ve done with them, from the challenge to the solution and their fantastic reviews. Click the buttons below to find out more about each.