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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)


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.

Bei der Arbeit

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: 

  1. You need to build QMS & get ISO13485 - 12 months.

  2. Create your own technical product documentation & get CE mark (duration up to 2 yrs)

  3. 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


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


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

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


Success rate in registrations

Yearly cost

Bildschirmfoto 2023-11-11 um 12.47.37.png

Based on survey

Gruppe Seflie


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.



Albert-Haueisen-Ring 70, 67071 Ludwigshafen, Germany

+49 173 4504624

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Congratulations, you journey starts now !

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