References

Our references seeing
at one glance.

LISA laser products OHG

Regulatory Affairs & QA Consultant

  • Development and Implementation of an ISO 13485, EN 62304 as well as ISO 14971-conform Development-Process
  • Support regarding the validation of the new process. Applying the new process to a medical laser project (class IIb, CE & FDA clearance)

PARAVAN medical GmbH

  • Support in ISO 13485 QA  and in regulatory affairs of a class IIa medical device in the field of rehabilitation taking EN 60601-1 series and EN 12182 into account

Rowiak GmbH

Optical design of a medical illumination system

  • Theoretical calculation and simulation of a medical illumination system including a risk analysis taking DIN EN 62471 into account

Alpha Laser GmbH

Development of a laser source 

  • Management of the development of a high-power laser source for industrial applications
  • Prearrangement of the product development by feasibility studies
  • Support of the development by optical calculation and test setups as well as verification of these

IROC AG

Development of an optical therapy system

  • Management of the product development process based on the company’s ISO 13485 QMS
  • Development of the optical system including optical simulations and risk analysis taking DIN EN 62471 into account
  • Verification of the project results
  • Support during the validation process
  • Prearrangement of the product certification

TAD Medizintechnik

Support of ISO 13485 certification and regulatory affairs

  • Prearrangement and support of the company’s ISO 13485 certification.
  • Completion with external audit by the notified body
  • Regulatory affairs regarding a class IIa medical device taking EN 60601-1 series and EN 12182 into account

Medixess GmbH

Consulting

    • Regulatory affairs consulting regarding class IIa and IIb products
    • Quality management consulting regarding ISO 13485 certification

    Elma GmbH & Co.KG

    Consulting

    • Consulting regarding IQ, OQ, PQ requirements according to international GMP of a class I medical device

    Klarlite GmbH

    CE-certification of a class IIb medical device

    • CE-certification of a class IIb medical device taking EN 60601-1 series and EN 60825-1 into account

    elexxion AG

    1. Head of development department

    • Management of the complete development process - budget and timeframe responsibility
    • 3x product development projects, as well as 1 design-to-cost project including regulatory affairs with successful CE certification of class IIb medical devices; especially focus on EN 60601-1-series and EN 60825-1
    • 2x successful FDA-510(k) certifications of class IIb medical devices taking UL/CSA as well as CDRH-requirement into account

    2. Support of the development team

    • Management of the development and regulatory affairs regarding a sub-assembly of a laser system
    • Theoretical simulation of an optical system
    • Support regarding the development of a medical laser source

    3. Development project, dental laser system

    • Management of the product development process, complete development starting with specs sheet via component and system development to start of serial production, regarding the regulatory affairs and the company’s QMS-ISO 13485 boundary conditions as well as budget and time frame. Development according to EN 60601-1-series and EN 60825-1

    4. Optical Design Laser-Handpiece

    • Development of an optic-concept and simulation of a medical Laser- Handpiece  taking regulatory and company requirements into account

    Laser Zentrum Hannover e.V.

    • Completion of a Proof of Concept-project in the field of laser technology
    • Realization of a laboratory setup of a diode-pumped solid-state laser for ophthalmic surgery
    • A lot of small projects within laser technology, e.g. optimization of material removal by a flashlamp-pumped erbium laser system