Get your device approved, in every market that matters.
Maven takes medical device and IVD manufacturers from gap assessment to approval — CE marking, US FDA 510(k), UKCA and CDSCO — backed by ISO 13485 quality systems and a team of 100+ specialists.
- CE certifications
- 300+CE certifications
- US FDA 510(k)
- 50+US FDA 510(k)
- Manufacturers served
- 350+Manufacturers served
- Consulting since
- 2016Consulting since
Manufacturers across Europe, North America and Asia trust Maven with their regulatory submissions.
Where you need approval
Four regulatory pathways, one team.
Most manufacturers come to us for one market and stay for the next three. Pick where you are headed.
Europe (CE Certification)
EU MDR & IVDR technical documentation, clinical evaluation, notified body audit support.
USA (US FDA 510(k))
Predicate strategy, eSTAR submission, establishment registration and US Agent.
UK
UKCA marking, MHRA registration and UK Responsible Person services.
India
CDSCO test, manufacturing, import and loan licences, plus Schedule V QMS.
No cost, no obligation
Not sure which class your device falls under?
Classification drives everything that follows — the conformity assessment route, whether you need a notified body, and how much clinical evidence you have to produce. Getting it wrong is expensive. Send us the device and we will tell you where it sits.
Under EU MDR a device falls into Class I, IIa, IIb or III. The rule that applies is as important as the class itself — we give you both.
- 1Describe the deviceProduct name and intended purpose. That is all we need to start.
- 2Tell us where to send itName, company, email and phone, so the result reaches the right person.
- 3We come back with the classReviewed against the EU MDR classification rules by a regulatory specialist.
Across every market
The work that does not stop at approval.
Market entry is one project. Staying compliant is the rest of the product's life. These run alongside every pathway.
QARA Services
Quality and regulatory affairs run as an extension of your own team, not a one-off project.
MDSAP
One audit accepted across Australia, Brazil, Canada, Japan and the USA.
Biological Evaluation
ISO 10993 biocompatibility strategy, gap analysis and evaluation reports.
Cyber Security
Security risk management and documentation for connected and networked devices.
IEC 62304 — Software Lifecycle
Software lifecycle processes and documentation for SaMD and embedded software.
Clinical Investigation
Investigation planning, site and ethics submissions, and evidence generation.
Why Maven
Regulatory work is judged on what happens when something goes wrong.
A deficiency letter, an audit finding, a rule change three weeks before submission. What separates consultancies is who answers the phone then.
One Team. One Vision. One Maven.
About Maven100+ regulatory specialists
A team qualified in medical device regulation, not a broker passing your file to someone else. Big enough to start a project the week you ask.
A dedicated project manager on every engagement
One named person who owns your submission end to end. Clients tell us the follow-ups stop being their job — that is the point.
On site when it counts
Mock audits, notified body audit support and on-site visits. Most of this category works entirely remotely.
Every pathway under one roof
EU MDR, US FDA, UKCA and CDSCO, with the ISO 13485 quality system underneath all four. One team, not four vendors.
In their words
What manufacturers say after the certificate arrives.
“Working with Maven has been hassle-free and there were barely any follow-ups required. The team has always efficiently & timely conveyed all the deliverables… Timely arrival of required certifications and therefore enhancing our business process.”
Nirav KhuntEON Meditech Pvt LtdClient since 2017 · 2 CE certificates “I wanted to take this opportunity and appreciate the hard work Maven team has put in getting our CE certification. This was especially challenging given short turnaround time.”
Mr. Pradeep TrivediOrtho Max Mfg. Co. Pvt. Ltd.CE certification “I would like to appreciate level of service we've received from Maven Profcon Services LLP as highly professional, competent and proactive, maintaining agreed terms and at reasonable budget.”
Mr. Regimants BaranovskisSIA Simurg BalticumLatvia
Maven on the move
Meet us in person.
Thirty minutes at a stand covers what a fortnight of email will not. Book a slot and come with your device.
17–19 September 2026
Medical Fair IndiaBombay Exhibition Centre, Hall 4 · Mumbai, India
Book a meeting16–19 November 2026
MEDICAMesse Düsseldorf · Düsseldorf, Germany
Book a meeting25–28 January 2027
WHX DubaiDubai Exhibition Centre · Dubai, UAE
Book a meeting16–18 June 2027
WHX MiamiMiami Beach Convention Center · Florida, USA
Book a meeting
Resources
Most people find Maven through something we wrote.
The reference material is free and it stays free. Use it, and come to us when the device in front of you needs a decision.
150 articles
The regulatory library
EU MDR, 510(k), UKCA and CDSCO explained by the people filing the submissions — ISO 14971, EUDAMED, implant cards, ETO sterilisation, GSPR.
89 documents
Templates you can start from
Risk management files, IFU checklists, packaging specifications and procedures — drafted to the standard, ready to adapt to your device.
Start here
Tell us about the device.
A short description is enough to tell you which pathway applies, roughly how long it takes and what it will cost. No obligation either way.
- India
- J-House, KP Epitome, Nr. Siddhivinayak Tower, Makarba, Ahmedabad, Gujarat, India 380051
- Canada
- 690 Little Grey St, Unit 134, London, ON N5Z 4M9, Canada