Dr. rer. nat. Christoph F. Wyss
Dipl. Biol., Registered Toxicologist in the European Union (ERT) and Switzerland
Consultant in Toxicology & Risk Assessment
Managing Director and Founder
Experiences
Chris has over 20 years of experience in toxicology in manifold fields
Performed > 100 chemical safety and risk assessments
Regulatory:
European Union Medical Device Regulation EU MDR No. 2017/745
EU REACH Regulation 1907/2006
Classification, labelling and packaging of substances and mixtures (CLP Regulation) Regulation (EC) No 1272/2008
The EU Cosmetics Directive (76/768/EEC)
Guidance:
International Standard ISO 10993 series on Biological Evaluation of Medical Devices
OECD Test Guidelines Program to assess the safety of chemicals
International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
Teaching in basic toxicology
Invited reviewer
Workplace exposure assessments
Permitted daily Exposure (PDE) determinations
Systematic literature searches
Excellent knowledge of GLP regulations
Proven ability to meet deadlines
Fluency in German, English and French
Personal features: excellent interpersonal, analytical and communication skills
Ability to build effective working relationships, team player
Simona Rohrer
BSc Pharm. Sciences, MSc Toxicology
Registered Toxicologist in the European Union (ERT) and Switzerland
Consultant in Toxicology & Risk Assessment
Experiences
Simona has over 5 years of experience in the medical device industry (biocompatibility, toxicology)
Experience in the analysis and toxicological risk assessment of particles
Performed numerous safety and risk assessments
Permitted daily Exposure (PDE) determinations
Excellent knowledge of GLP regulations
Regulatory:
European Union Medical Device Regulation EU MDR No. 2017/745
Classification, labelling and packaging of substances and mixtures (CLP Regulation) Regulation (EC) No 1272/2008
Guidance:
International Standard ISO 10993 series on Biological Evaluation of Medical Devices
OECD Test Guidelines Program to assess the safety of chemicals
International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
Systematic literature searches
Personal features: Quick comprehension, analytical thinking, passionate learner, team player
Fluency in German and English
Proven ability to meet deadlines
Other Employees
Max Mustermann
Business Owner
Max Mustermann
Business Owner
Max Mustermann
Business Owner