About us
We are specialist for
We are an expanding regulatory affairs consultancy supporting medical device manufacturers in their ability to develop and offer best medical products to patients, including innovative treatment.
MaxCert will provide you strategic advice and tailored solutions to effectively overcome your regulatory challenges during the entire lifecycle of your company medical products.
ISO 13485
MDR Certification
Technical Docs
Strategic Roadmap
Easy ways to
Strategic Roadmap
Easy ways to
get ready your work
Maxcert’s team has expert knowledge to help you navigate through the complex regulatory challenges that the new EUMDR bring. We can assist you through out the entire process to ensure that you and your business are compliant with all of the EU-MDR requirements.
Contact us first
We would love to hear from you, just call us or leave us an email.
Consult with us
Our experienced MDR consultant will contact you ASAP, to talk to you about your project.
Place order
Once you are convinced with our services, you may would like to place us an order.
Give us payment
After signing the agreement and agreed terms & conditions, we keep you posted on project updates.
Features
We serve by
Quality of services
We serve by
maintaing Regulatory Support across EU
Regulatory Affairs in Europe can be a complicated process. It’s important for regulatory affairs team to navigate, not only the local laws but also international agreements between countries – something that is difficult when dealing with multiple languages.
Features
We develop our templets
Quality of services
We develop our templets
with new regulatory changes
Is your regulatory team under burden with new/ often changing regulations? Our experts make the best use of their expert knowledge to keep your documentation upto date.
Services
Our best services to
Services
Our best services to
solve your MDR hurdles
Our experienced consultants will evaluate the most appropriate strategy to register your product in Europe and beyond. Full support can be provided to prepare the registration file, support with the validation phase, the Response to Questions and provide full local launch support.
European Representative
We are officially authorized by EU authorities to act as your Representative in European Union & United Kingdom, send us an email to receive quote today.
EUDAMED Registration
From SRN & Registration of devices / UDI and Traceability EUDAMED & Guidance on UDI for systems and procedure packs
PRRC Services
Person Responsible for Regulatory Compliance (PRRC), You must not hire a regulatory employee as an SME, Use ours & save money to spend on your product developement.
Group members
Meet with our expert team
We have Medical device experts
Looking for the right
regulatory experts?
Our clients treasure that we share their passion, commitment, and values, all from an understanding of their position and business challenges – our experience means we are able to put ourselves in their place.
Super responsive
Our experts are just a call away from your reach
Very easy to communicate
Our experts can speak many language, can make your life easier
Years of Experience
Our experts are trained ex employees of Notified bodies and know very well all regulatory wayouts.
We are ready to serve you
Medical Devices Manufacturers, we help you overcome regulatory hurdles
About us
Our many years of experience is
the main reason of success
Expert team
Completed projects
Happy customers
Pricing
You will get best
offer saving time and money
Maxcert tean allows you to reduce your working hours while saving costs on your medical device registrations.
our blog
Learn more from
our blog
Follow our latest news and thoughts which focuses exclusively on design, art, vintage, and also work updates.
Testimonials
We help our clients stay in compliance
Together we set up a 13485 QM system from scratch and had it certified. Very good support through the entire certification phase; We are very satisfied!
Christian Müller
Founder, Surgi Industry
Top performance, top service! Unreservedly recommendabl. We were short with our Audit appointment and at last moment we contacted MaxCert team and with success! Thanks
Jürgen Trautner
Managing Director
Top professionell, zuverlässig und gut vernetzt.
Johnson Salzberg
Managing Director
182-184 High Street North
E62JA, London, UK
Email: info@max-cert.com
Phone: +44 077 6195 66 13
Phone: +44 077 6195 66 13
Having trouble? Find the answer to your query here. Don’t hasitate to contact us!