MEDICAL DEVICE

Our Services

The new standards ISO 10993-1:2018 and ISO 14971:2019 clarify many points on the biological assessment process of medical devices. Toxi Plan supports biological evaluation as well as manufacturers to meet regulatory requirements.

There are a lot of borderline cosmetic products and the transition from cosmetic product, concerned by the cosmetic regulation 1223/2009/EC, to medical device, concerned by the standards ISO 10993-1:2018 and ISO 14971:2019 and the medical device regulation (EU) 2017/745, is a challenge for the cosmetics industry.

Thanks to the pharmaceutical and cosmetic experience of our chemists and toxicologists, Toxi Plan provides services to evaluate biological safety of medical devices.

ANALYSIS OF BORDERLINE COSMETIC PRODUCTS

TRANSITION FROM COSMETIC PRODUCT TO MEDICAL DEVICE

CHEMICAL PROFILE

ANALYTICAL PLAN

CHEMICAL CHARACTERIZATION MANAGEMENT

RISK ASSESSMENT REPORT

BIOLOGICAL TESTING PLAN

MANAGEMENT OF BIOLOGICAL STUDIES

INTERPRETATION OF RESULTS

BIOLOGICAL EVALUATION REPORT (BER)

BIOLOGICAL ASSESSMENT AUDIT

BIOLOGICAL ASSESSMENT TRAINING

Focus on

CHEMICAL CHARACTERIZATION MANAGEMENT

Toxi Plan handles the characterization of the active ingredients and degradation products in the medical device. We collaborate with laboratories that have the necessary scientific equipment to perform UV-Vis spectroscopy, Nuclear Magnetic Resonance (NMR) spectroscopy, mass spectrometry, high performance liquid chromatography (HPLC) etc.

BIOLOGICAL TESTING PLAN

The risk assessment takes into account available data and chemical characterization results. After this first assessment, Toxi Plan prepares biological testing plan depending on nature of medical device, contact area and contact duration.

BIOLOGICAL ASSESSMENT TRAINING

We provide trainings on biological assesment for medical devices to professionals and students. In 2019, we are involved in business incubators dedicated to natural cosmetics (e.g. La Fabrique 621 in Paris) and Masters’ degrees in toxicology and ecotoxicology of French universities (e.g. the University of Toulouse III Paul Sabatier, the University of Angers).

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RAW MATERIAL

(quantities ≥ 1 tonne/year)

cosmetic ingredient
cosmetic product
biodegradable packaging
apparel, footwear

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