01MDRRegulation (EU) 2017/745
02NB 2764Designated conformity assessment
03ISO 13485Accredited QMS certification

Within controlled scope

Assessment shaped around the product lifecycle

Each service is translated into controlled projects using the scope, device and competence codes confirmed during application review.

Woman vascular physician performing ultrasound-guided endovenous laser catheter treatment on a patient’s leg
01

MDR conformity assessment

Product and quality-system assessment for medical devices within NOTICE’s designated scope.

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02

ISO 13485 certification

Quality-management-system certification for medical-device organizations, delivered by competence-matched teams.

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03

Post-certification lifecycle

Surveillance, change, recertification and certificate-status activity in one traceable record chain.

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Device technology spectrum

From non-active implants to software-controlled systems

The assessment approach reflects the different risk and evidence profiles of implantable, active, robotic and software-enabled medical devices.

Orthopaedic implant components with restrained orange technical contours
01

Implantable and non-active devices

Integrated review of materials, biocompatibility, mechanical performance, sterilization and clinical evidence.

Robotic surgery system with restrained orange technical contours
02

Active and robotic systems

Electrical safety, usability, interoperability, cybersecurity and system-verification evidence.

Patient monitor and medical-software interface with restrained orange technical contours
03

Medical-device software and monitoring

Software lifecycle, clinical function, alarm management, data integrity and human factors.

Image sources: Wellcome Collection / Science Museum (CC BY 4.0), Stefan Maritz and Anna Shvets / Pexels. Orange technical contours are NOTICE staging derivatives.

End-to-end control

Know what happens at every stage

Customers see progress and what is expected from them. Authorized NOTICE teams govern scope, assignments, evidence, timing and decisions.

View the certification process
  1. 01Registration and application
  2. 02Scope and application review
  3. 03Agreement and project setup
  4. 04Parallel product and QMS assessment
  5. 05Independent review and decision
  6. 06Certificate and surveillance

International network, specialist local team

Part of Applus+ Laboratories

NOTICE joined Applus+ Laboratories in 2025, bringing independent certification governance together with an international testing, inspection and certification network.

Read the corporate announcement

Public trust

Verify a NOTICE certificate

Enter the verification code shown on the certificate. Verification is performed by the secure NOTICE portal.