Medical devices
- Advice on the implementation and advertising of observational studies according to the new German medical devices implementation act
- Advising companies on the import and marketing of mouth protection masks during the Covid-19 crisis
- Advising a US company on clinical trials for tissue products and on product classification issues pursuant to the new EU Medical Devices Regulation 2017/745
- Adapting various OEM-QS and Responsible Person agreements to the legal requirements stipulated in the new EU Medical Devices Regulation 2017/745
- Advising an international medical devices distributor on the sponsorship of events for physicians and existing legal boundaries due to anti-corruption regulations and industry codes.
- Advising an Austrian health products company on the switch of various products that are no longer marketable as medical devices under the new EU Medical Devices Regulation.
- Preparation of various clinical trial contracts for medical devices and in-vitro diagnostics companies
- Advising a distributor of foot care products on the product switch from cosmetic products to medical devices
- Comprehensive consulting for a Canadian manufacturer of high-quality kinesiology tapes in European medical device law (e.g. preparation of documents for the conformity assessment procedure, for advertising and labelling of the respective products)
- Advising a manufacturer of innovative corneal cross-linking products on specific regulatory and strategic issues in the field of European medical devices law
- Advising a PE investor/spin-off of a medical device manufacturer on a complex development contract for respiratory therapeutics
- Regular advice to manufacturers of medical devices in the fields of dental products, prostheses and material medical devices in the field of therapeutic products advertising law