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Who we are

Loran is a consulting company specialized in the healthcare sector. Loran has many years of experience in drafting and monitoring regulatory requirements in the field of medical devices and medicinal products in the EU. The regulations of the MDD as well as the relevant guidance documents (EK-Med, NB-Med, MEDDEV, ...) up to the pre-parliamentary drafts of the Medical Device Regulation (MDR) have been actively shaped by our consultants for more than a quarter of a century. Loran's clients include medical device manufacturers, importers, distributors, suppliers, service providers as well as associations and M&A companies.

 

Why we exist

Loran GmbH was founded in 2020 with the aim of offering manufacturers of medical devices and other economic players sound and legally secure advice on strategic alignment issues and their regulatory and technical implementation.

What makes us stand out

The experience of the two managing directors and their access to a wide network of senior experts in various fields such as, medicine, law, development and manufacturing guarantees compliance with the applicable legal requirements of the MDR (Regulation 2017/745) and IVDR (Regulation 2017/746) and adjacent legal areas for both established companies and startups in the healthcare sector.

Your contact persons

Jörg Wilke

Dipl. Chemical Engineer

Management

CV/ Qualification

  • Studied chemical engineering (biotechnology) and mechanical engineering

  • working in the health care sector since 1992:

    - in different contract laboratories in the fields of clinical chemistry, microbiology, clean room technology
    - there responsible for method development, quality management as well as certification and accreditation
    - as owner, managing director, technical manager of a notified body for medical devices
    - Support of several hundred customers in the EU, Asia, Africa and the USA
    - Experience with various manufacturing processes through more than 1500 audits at manufacturers and suppliers of medical devices as well as through
    - numerous audits of technical documentation in areas such as cardiology, infusion technology, orthopedics, wound care and material medical devices

  • > 25 years active in standardization in national mirror committees and international working groups in the field of cleanroom technology and sterilization, long-time chairman of the Horizontal Working Committee "Cleaning - Disinfection - Sterilization" ("HAK RDS") of the ZLG

Uli Rennen

Lawyer

Management

CV / Qualification

  • Legal expert

  • Practicing as lawyer between 2010 and 2024 with main focus on:

    - medical law, in articular medical device law
    - contract law
    - labor law
    - civil and administrative law

  • Lead Auditor DIN EN ISO 13485 (BSI)

Convinced?

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