Product management, regulatory affairs, international certifications and product approvals

ascendi MEDIZINTECHNIK - Bavaria
Medical devices - development compliant to Regulatory Affairs and market requirements

Professional product management for medical devices.
Specialities: Regulatory Affairs, international Certifications and product Approvals, Requirements Management, Development Controlling

Product range: Medical Imaging (CT, MSOT, NMR), General surgery (HF, US Generators), Plasma Kinetic Intruments for MIS, Cardiopulmonary devices, Optical devices (Endoscopes), Ophthalmologic devices, Medical stand–alone Software, dental products.

Development of medical devices compliant to Regulatory Affairs and Market Requirements for international markets.

What we offer

- Regulatory affairs, international certifications
(CE, FDA, CMDR, TGA..)
- approval oriented development, requirements management
e.g. IEC 60601, 62304, 62366, 14971, UL, NEMA, part11
- QM-Systems ISO 13485, 21 CFR 820
- Project-management; reporting system for verification and reviewing progress, time and costs
- Development coordination and controlling
- Preparing FDA-Audits
- Providing market information
- Preparing product launch; product positioning, marketing concept.

What we are looking for

Institutions, founders or established companies with innovative ideas to develop them to medical devices and launch them on the international market.

We are looking for real Partners (national and international) to provide our solutions for customers.
In the fields of:
Finance, Marketing, Distribution, Developers/Engineers

Keywords

  • Medical Technology
    • [offer] Dental instruments, surgery and technologies
    • [offer] Electrosurgery, cryosurgery, lasersurgery
    • [offer] Endoscopy, laparoscopy
    • [offer] Equipment for hospitals etc.
    • [offer] Equipment for Surgery Rooms
    • [offer] Medical and electromedical instruments and devices
    • [offer] NMR, CT, PET, 3D-Imaging
    • [offer] Ophthalmology
    • [offer] Regulatory services
    • [offer] Telemedicine, home care
    • [offer] Ultrasonic diagnostics and therapy
    • [offer] X-ray diagnosis and therapy

Collaboration sought

  • Research & development
  • Partnership for international development projects

Responsible

Owner

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