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.)
- CAD/CAM
- 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.
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?
Specialist for
surgical and dental
instruments and
implants
Scalable manufacturing capacity
Vast experience
in regulatory affairs
Full Service –
Tier 1 Supplier
Independent,
family-owned
company for
over 100 years
State-of-the-art
production
technologies and
processes