Medical Devices Regulatory Affairs

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Description :: Training:

Train specialists in regulatory affairs and thus train qualified people in the medical device in the context of the new European regulation that aims to master 2.
This master was created in collaboration between Lyon and Polytech ISPB (Institute of Pharmaceutical and Biological Sciences) and in synergy with the SNITEM (Nationnal Union Medical Technologies).

Summary :: Training:

The training is based on three core competencies:

- Knowledge of the technical and regulatory aspects of medical devices

- Control of regulatory aspects of medical devices

- Management and management of accreditation and its consequences (legal, financial, logistics samples).

:: Audience and Prerequisites:

- Students engineers from the following courses: BioMedical Engineering (BME), Electronics, Bioengineering, ...

- Holders of M1 areas engineering to health or medicine, physics, instrumentation, electronics, biotechnology, biology, biochemistry.

- Students of Pharmacy

- Businesses wishing to move their functions under the VAE or Continuing Education

:: Skills acquired in this training:

Mastering the technical and regulatory aspects of the medical device in a broad sense. Read implement a quality approach to a hospital technical platform.

be able to implement the placing on the market of a new medical device under the new European regulations.

Understand and participate in the management of a medical device company.

:: Further studies and opportunities:

- Technical framework in business or public or private institution whose mission is to care accreditation of medical devices or the establishment of a system of quality management in relation to the technical platforms.
- Applications Engineer in the field of medical device regulatory

Features :: and access conditions:

- Students who have completed their Polytech engineering 4th year
- Graduate engineers wishing to specialize in the area concerned
- Holders of M1 areas of health technologies or medicine, physics, electronics, biology, biochemistry

Terms :: Registration:

Eligibility and admission on file after an interview.
Date of hearing: see registration form (CIELL2)

Terms :: Knowledge Assessment:

Teaching units are assessed by continuous assessment (projects) and final examination.
The company mission is assessed by a probation report, assessing the company tutor and an oral

Employees :: previous years:

Proposed in 2013 training

:: Success rate of previous years:

New Training

Wiley-Blackwell Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices
Book (Wiley-Blackwell)
2006-02-20 17:02:02 by Bioseeker

8 years in biotech

I've been working consistently in the biotech field, after a BA in Psychobiology for 8 years.
-Regulatory Affairs deals with getting FDA approval of new drugs and medical devices.
I went to the Biospace job fair last month but haven't got any calls. I'm wondering if its b/c I currently reside in LA. I'm thinking of moving down there and looking for something fast thru a temp agency. Any advice?

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