OEM SolutionsReseller Section

Inspection, Regulatory Affairs,
and Quality Management

Key advantages at a glance:

  • ISO 13485, ISO 13485 MDSAP, and ISO 9001 certified
  • EU-MDR and FDA compliant
  • Extensive market knowledge as a legal manufacturer of our own products
  • State-of-the-art inspection technologies
  • Private Labeling solutions
  • Support for developing and maintaining of technical files
  • Expertise in compliance agreements

With our extensive experience in the medical technology industry, you can rely on our expertise, compliance, and quality for your medical device.

Certifications and Compliance

We operate with a quality management system in compliance with EU-MDR and FDA standards, certified according to:

  • EN ISO 13485
  • ISO 13485 MDSAP
  • ISO 9001
  • Directive 93/42/EEC
  • MDR - REGULATION (EU) 2017/745

Legal Manufacturer of Our Medical Devices

Acting as a legal manufacturer of our own products in the medical technology industry, we understand our customers' challenges in documenting and registering their medical devices. This market knowledge allows us to engage with you at eye level and provide the best possible targeted support.

Technical Documentation Support

Our highly qualified and experienced team is ready to assist you with expertise and dedication in setting-up and updating your technical documentation for a reduced time to market, including:

  • FMEAs
  • Risk management / Hazard list / Biocompatibility
  • Verification and Validation
  • Statistical process control (SPC/CAQ)
  • Process validations for all special processes (electropolishing, hardening, passivation, cleaning, packaging, etc.)
  • and more

Private Labeling

We not only support you in setting up your technical product file as a contract manufacturer, but can also take over the entire documentation for you in the role of legal manufacturer with our Private Labeling solutions.

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Regulatory Expertise

On request, we provide support for:

  • Compliant labeling
  • CE and FDA registration
  • Country registrations
  • Canadian Licensing
  • PMA (Premarket approval) submissions
  • Pre-market Notification

Contracts and Agreements

As a reliable and experienced partner, we establish the foundation for ensuring our customers' compliance with regulatory and quality assurance agreements.

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Why Komet Medical?

Learn more about us

Komet Medical

Specialist for
surgical and dental
instruments and

Komet Medical

Scalable manufacturing capacity

Komet Medical

Vast experience
in regulatory affairs

Komet Medical

Full Service –
Tier 1 Supplier

Komet Medical

company for
over 100 years

Komet Medical

technologies and