Robotic surgical system in a bright clinical operating environment

Active devices · robotic surgery

Certifying innovation. Protecting patients.

Independent conformity assessment for advanced active and robotic medical-device systems.

Explore certification services NB 2764

Clinician reviewing a modern patient monitor in a clinical environment

Software · AI · patient monitoring

Intelligent devices. Evidence you can trust.

Assessment of clinical software, algorithm lifecycle, monitoring performance and data integrity.

View the assessment process NB 2764

Network-connected hospital monitoring and infusion equipment in a bright care environment

Connected devices · secure lifecycle

Connected care. Controlled cyber risk.

Evidence-led review of secure design, data flows, update controls and post-market vulnerability handling.

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Modern orthopaedic implant components prepared for inspection

Implantable · non-active devices

Engineered to remain. Assessed to endure.

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

Discover our scope NB 2764

Cardiac catheterization team working in a controlled clinical laboratory

Interventional · sterile devices

Precision through every pathway.

Evidence-led assessment for catheter systems, guidewires, sterile barriers and critical manufacturing processes.

Start an application NB 2764

Medical-device manufacturing team working in a controlled clean production environment

Manufacturing · quality systems

One lifecycle. Every critical control.

Conformity assessment across product realization, controlled production, sterile processing and quality systems.

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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.

Clinical team performing a cardiac catheterization procedure in a controlled laboratory

MDR conformity assessment

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

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ISO 13485 certification

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

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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

Implantable and non-active devices

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

Robotic surgery system with restrained orange technical contours

Active and robotic systems

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

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

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

01Registration and application
02Scope and application review
03Agreement and project setup
04Parallel product and QMS assessment
05Independent review and decision
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.

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Current and traceable

Fast access to controlled information

Browse controlled resources

Application resourcesWith code, revision and language Regulatory updatesWith source and effective date Complaints and appealsIndependent controlled handling

Public trust

Verify a NOTICE certificate

Enter the certificate number for a legacy record or the validation reference shown on a current certificate. Verification is performed by the secure NOTICE portal.