Regulatory compliance , made clearer.
C-REG Medical helps small to medium-sized manufacturers and distributors of medical or in-vitro devices achieve and manage compliance with American, European and other International regulations.
The aim is to help companies sell their devices and products on world markets, with close and personalised support from Tim Lawton.
Tim Lawton
PRINCIPAL REGULATORY CONSULTANT Founder, C-REG Medical SARLChartered Engineer (IET) & RAPS Member with extensive UK & European medical device industry experience since 1996.
- Direct 1-on-1
- US FDA 510(k), De Novo & PMA Guidance
- European MDR (2017/745) & IVDR (2017/746) Compliance
Direct Expert Accompagnement
Personalized regulatory strategy tailored specifically for medical device & diagnostic innovators.
Founded in September 2006 by Tim Lawton, C-REG Medical SARL was established to provide direct, hands-on regulatory affairs and quality assurance consulting to small and medium enterprises (SMEs). Operating as a Limited Liability company ('SARL') since February 2008, C-REG Medical is led solely by Tim Lawton.
Unlike large multi-layered agencies where your project is passed down to junior staff, working with C-REG Medical means you deal directly with Tim Lawton at every step of your regulatory compliance journey.
Solo Expert Focus
Direct one-on-one communication.
Tailored SME Approach
Pragmatic compliance strategies scaled to your company size and timeline.
Dual Market Expertise
Comprehensive alignment with US (FDA) and European (MDR\IVDR) standards.
Tim Lawton – Regulatory Affairs & QA Expert
Tim Lawton helps manufacturers and distributors of medical and in-vitro devices achieve and manage compliance with USA, European & other international regulations.
Tim LAWTON
PRINCIPAL CONSULTANT & FOUNDER BEng (Hons), RAPS Member, Chartered Engineer IET Connect on LinkedInTim LAWTON first started his career in England as an Engineer in manufacturing (Manufacturing Systems Engineer, BEng, University of Hertfordshire). He acquired a significant experience as Manufacturing Engineer, Manufacturing Manager, and Quality Assurance Manager.
Established in France since 1996, he worked as Quality Assurance and Regulatory Affairs Manager with manufacturers of medical devices and in-vitro devices.
He set up his own company in September 2006 (C-REG Medical), committing himself to helping small & medium sized companies with their regulatory issues, to provide a close and efficient accompaniment where it is needed.
Targeted Regulatory & Quality Services
Focusing on key intervention areas to safely accelerate global market access.
Regulatory is not a stand-alone put it in a corner thing... but a major integrated company project management problem !
US FDA Regulatory Access
Guidance on 510(k), De Novo, PMA, and Q-Submission strategies, FDA product classification and direct liaison representation.
Business needs
From due-diligence audits to time-to-market evaluations (budget, resources, regulatory pathway) through to the out-of-the-box strategies that make the difference (how not to be a medical device, business risk vs regulatory, ...).
ISO 14971 Risk & SaMD
Structured risk management analysis and compliance strategies for Software as a Medical Device (SaMD), Cybersecurity and AI / ML needs.
European MDR / IVDR Conformity
Technical documentation review, Notified Body preparation, and compliance strategies for EU Directives.
Quality Systems
Implementation & alignment of Quality Management Systems including ISO 13485, QSMR, 21 CFR 803 & 806, 21 CFR 820
Post-Market Vigilance & Training
Setting up user and distributor post-market vigilance systems alongside customized team training programs.
Target Markets: US, Europe & other
International Markets
Comprehensive regulatory alignment across major global jurisdictions.
US Regulatory Access (FDA)
Whether you are thinking about selling on the US market or working on your submission project, high-level expertise addresses your exact needs.
European Market Access (CE Marking MDR / IVDR)
Guiding your medical device onto the European market with seamless regulatory transitions.
Other International Markets
Overcoming complex international barriers across global markets.
Have You Thought About Tailored Team Training?
Your regulatory issues can be first addressed by training your team involved in FDA or CE marking projects.
Programs are customised taking into account both to your team's technical profile & your regulatory business needs.
Working with C-REG Medical
A close and efficient partner in France for your regulatory issues.
Established in France
Set up in Candillargues (Montpellier region, France), providing direct, local European presence.
Direct Lead Expert
C-REG Medical is me — Tim LAWTON, established in France since 1996 with extensive QA/RA experience.
Bilingual Fluency (EN / FR)
Fluent in English & French, ensuring clear communication with French (ANSM) and International regulatory bodies (FDA, EMA).
Diverse TPE & SME Solutions
Wide array of solutions tailored to fit the exact requirements and budget of small & medium companies.
Personalized Accompagnement
Ensures close, dedicated accompagnement for each client company, big or small whatever their size & needs.
Global US & EU Coverage
Dual US and European regulatory scope enabling a streamlined global approach to market access.
Decades of Engineering & Quality Mastery
BEng Manufacturing Systems Engineer (University of Hertfordshire, UK)
Member of RAPS (Regulatory Affairs Professional Society)
Chartered Engineer Member of the IET (Institution of Engineering & Technology)
Contact Tim Lawton Directly
Whether you need brief advice or complete regulatory management, reach out today.
Send a Direct Message
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Tim Lawton will personally evaluate your regulatory scope and contact you directly within 24 to 48 business hours.