CONTRACT LEGAL MANFACTURER - EU/UK REP - CONSULTING
ADHOCON Contract Legal Manufacturer (CLM) service is for people who believe that
AI and software will disrupt healthcare
We focus on people who want to
be compliant in all markets - now.
We promise that engaging with us will help you be
in US, UK, EU and 103 other markets
quicker and cheaper to help patients and clinicians
About us
ADHOCON is an ISO13485:2016 certified & ISO27001 compliant Contract Legal Manufacturer and consulting company with a team that has over 50 years experience in medical devices, Software as Medical Devices (SaMD), AI, Digital Therapeutics (DTx), IVDs and pharmaceutical products.
We are based in Germany, United Kingdom and Dubai (UAE) and are Authorized Representative (AR) and PRRC in UK & EU.
We have registered and filed more than 200,000 products in US, EU, UK and 103 other countries worldwide.
Our AI supported and approved lean QMS is helping clients to focus on what they are good at, disrupt healthcare and product development.
We cover all classes of medical devices (except implantable devices)
Challenges
For AI in healthcare, Software as a Medical Device (SaMD) and DTx there are already regulations in place which have to be followed in order to offer your product on a market.
Especially in an early phase of your development being compliant to regulation could be a competitive advantage and create trust amongst investors and customers.
Mandatory regulation to be covered with your own QMS you need implement:
US FDA 21CFR820, EU MDR ISO13485, ISO14971, ISO14155, ISO18969, IEC62306, 62366, 82304 CyberSecurity, GDPR
This may block your product development and requires a lot of resources
You want to develop best in class products - Quality & Regulatory support is expensive.
And you need to deal with many regulators and agencies: Notified Body, country authorities, consultants, Authorized Representatives
It takes too long:
-
You need to build QMS & get ISO13485 - 12 months.
-
Create your own technical product documentation & get CE mark (duration up to 2 yrs)
-
US FDA registration 3-24 months
Without regulatory experience you may miss requirements and need to go back in dev
We'll get you covered immediately after contract
QMS
You are immediately compliant with our ISO13485:2016 certified QMS which meets all countries requirements and we are in charge to keep you compliant and up-to-date.
You don’t need your own QMS and ISO certification.
Faster go-to-market
Our QMS and technical documentation are ready for US, EU, UK and over 100 markets registration requirements. And no matter what the future regulation looks like:
All the time we keep all your documentation compliant.
Full service
With ADHOCON, as your contract legal manufacturer, you not only get a full QARA team bringing you to and keeping you on the market and maintaining your licenses.
We take all obligations off your shoulders to let
you focus on your product and customers.
Our Services
Contract Legal Manufacturer
ISO13485:2016 QMS
Compilation of technical documentation
Clinical obligations
Registration in all countries
Full responsibility for compliance
Quicker, cheaper and less internal burden
Consulting
We build the legal manufacturer capabilities in house and train your team including QMS, technical documentation and registration.
We also support investors with their investments or due diligence.
Experienced, plannable, and on-time results
Outsourcing of current
QA, RA & QMS
You are a legal manufacturer, but would like to outsource QMS, PMS, registrations or your quality and or regulatory resources?
No problem, we take your part over without interruption.
Structured, reliable and cost-saving
Your benefits
Quick and easy quality and regulatory compliance even when regulation changes.
Full quality and regulatory team on hand for the same monthly rate - we scale with your success.
50+% HR cost
less than 1FTE consultant or internal staff cost
6 months earlier
Save 6 months of leadtime implementing QMS and ISO certification
Save 40+k€
Save at least 40k € for ISO certification and eQMS Software
100%
Success rate in registrations
Yearly cost
Based on survey
Success
We believe in your product and that it will disrupt healthcare.
We will focus on you and your compliance.
We promise to bring your product to markets,
compliant to every existing or future regulation.
START NOW
ADHOCON UG
Albert-Haueisen-Ring 70, 67071 Ludwigshafen, Germany
+49 173 4504624