On this one-day-course you will get an introduction to the authority requirements concerning marketing of medical devices.
We will go through the basic principles for authority approval focusing on the information required for toxicological and clinical assessment of a medical device. During the day we will look at guidelines, test methods and internet databases.
Contents
- Regulation and directives
- Test guidelines
- Preclinical test methods
- Case story
- Clinical testing
- Internet databases
- Example of risk assessment
Target group
You have a basic biological or chemical understanding but need more background information on requirements from the authorities concerning marketing of medical devices.
Course manager
Karl-Heinz Cohr, chief toxicologist. Expert in human toxicology and risk assessments, in particular medical devices and pharmaceuticals. Extensive knowledge of EU legislations and preparation of dossiers.
Date
Tuesday 13 May 2008
Venue
DHI, Agern Allé 5, DK-2970 Hørsholm, Denmark
Price
DKK 4,050 exclusive of VAT. The price includes course materials, coffee/tea, lunch and a half-hour telephone consultation after the course.
Registration
Please register with Vibeke Salmon. Registration is binding.
The course is held in collaboration with aCROnordic A/S and Medical Device Consult (MDC).
aCROnordic A/S is a full-service Contract Research Organisation (CRO) operating in Scandinavia and internationally through an extensive network of local partners. aCROnordic provides strategic and scientific consultancy service and can assist at or conduct any level of the clinical research project, from writing the protocol, collecting the data to finalising the study report. During the past few years aCROnordic has increased activities within consulting related to medical devices.
Medical Device Consult (MDC) is a Danish based consulting firm founded in 1995. MDC assists medical device and in vitro diagnostic companies in meeting regulatory and quality system requirements within the EU, US, Canada and Japan. MDC offers a broad range of services to companies within the medical business from regulatory strategies in new product development, assistance in approaching authorities and notified bodies, establishment and maintenance of quality management systems to audits and mock inspections of companies prior to regulatory inspection.