Ensure the quality and regulatory compliance of your medical devices

For the past 25 years, Isocèle Conseil has been helping manufacturers, distributors, and authorized representatives ensure that their medical devices and in vitro diagnostic devices comply with the MDR and IVDR.

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My needs

Quality management system

  • ISO 13485:2016
  • MDSAP
  • FDA QMSR
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Regulatory Compliance / Market Access

  • CE Marking (EU)
  • FDA 510(k) USA
  • Canada Homologation
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Regulatory Monitoring

  • EU Regulatory monitoring
  • Export Regulatory monitoring
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Audits

  • Internal Audits
  • Subcontractor Audits
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Additional services

To help you complete the process, Isocèle Médical offers additional services specifically for medical devices.

25 years

expertise

+ of 500

clients and references

10 experts

aware of your realities

Who are we?

Isocèle Conseil offers its expertise in medical device regulations to manufacturers, distributors, importers, and innovative startups at every stage of their development—from design to market launch.

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  • Support

    Practical support right through to ISO 13485 certification

  • Compliance

    Compliant regulatory files ready for submission to notified bodies

  • Regulatory monitoring

    Customised regulatory and standards monitoring

  • Audits

    Internal audits of your quality system and your subcontractors

Breaking news

News

The European Commission has released a new update to its study on the availability of medical devices in Europe

21 Jul 2026 Read more

Reusable Surgical Instruments and EU Regulation 2017/745

21 Jul 2026 Read more

Biological Evaluation of Medical Devices

21 Jul 2026 Read more

Their experience with Isocèle Médical

“Your professionalism, attention to detail and availability were key factors in the success of our certification project. Thanks to your expertise and commitment, we were able to benefit from a reliable and efficient service, perfectly tailored to our needs.”

Less France Christophe Jansem

Isocèle Conseil has been supporting us since NovaGray was founded in 2015, offering consistent commitment and invaluable expertise. Thanks to their support in implementing our Quality Management System, we achieved ISO 13485 certification in 2018. Their thorough guidance on our internal audits...

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Novagray Clémence FRANC

As a young start-up in the medical devices sector, we were keen from the outset to learn best practice and invest in the quality of our future products. With the company having only just been set up, we enlisted the help of...

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Damae Medical David SIRET

As a manufacturer of Class I medical devices, we rely on Isocèle for regulatory support. Their expertise, responsiveness, and the quality of their advice are invaluable in a constantly evolving environment. They are a reliable and highly responsive partner we can count...

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Neo DTx Lola BELISSA

As a Toulouse-based small and medium-sized enterprise specializing in the design, manufacture, and sale of Class I medical devices, we have been working with Isocèle Conseil for the past year and a half to support us on two key initiatives: The Modernization...

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Alter Eco Santé
Alter Eco Health Etienne LALLEMENT

Our References

BRAINDEX

Manufacturer
Neurology, Psychiatry & Sleep
Compliance Quality +1 prestation
  • CE Marking under Regulation 2017/745 for a medical device for anesthesia optimization

PRECILENS

Manufacturer
Ophthalmology & Vision
Outsourced Quality Manager PRRC +2 services
  • Monitoring compliance with the ISO 9001 and ISO 13485 Quality Management Systems as an Outsourced Quality Manager
  • Internal Audit Training

HEARING SPACE

Manufacturer
ENT, Hearing & Tinnitus
Compliance Quality
  • Regulatory support for hearing test software designed for hearing aid specialists

IMAGINE EYES

Manufacturer
Ophthalmology & Vision
Audit Compliance +1 prestation
  • Implementation of the ISO 13485 Quality Management System - CE Marking (TÜV, May 2005)
  • Internal Quality System Audits

VEODIS Implant

Manufacturer
Orthopaedic Surgery & Implants
Quality
  • Implementation of the ISO 13485:2016 Quality Management System for Orthopedic Implants

X-os

Manufacturer
Orthopaedic Surgery & Implants
Compliance European Representative +2 services
  • Implementation of ISO 13485
  • Support for CE Marking of a Bone Lengthening Implant and Orthopedic Instruments
  • Outsourced Quality Manager Role and European Authorized Representative Services
All references