Biomedical Quality Management System Requirements

Biomedical Quality
Management System
Requirements

 Regulatory Laws and Requirements

1. FDA - Code of Federal
Regulations (CFR) Title 21
Identify, define, and apply the
following FDA requirement parts:
11-Electronic records and signatures,
801-Labeling, 803-Medical device
reporting, 806-Corrections and
removals, 807-Establishment
registration and device listing,
820-Quality system regulation
(includes preamble-FR October 7,
1996) and 821-Medical device
tracking.

2. U.S. requirements (FD&C Act,
201, 301-304, 501-502, 510,
513, 518, 704)
Identify how the FD&C Act defines
and differentiates between device
classifications and pre-market
requirements. Recognize the
implications of misbranding
and adulteration.

3. European directive: Medical
Device Directive 93/42/
EEC (MDD) 14 June 1993
(Article 1) as amended by
Directive 2007/47/EC.
Recognize requirements of the
directive and the key differences
between this and U.S. regulations.

4. Health Canada
Recognize requirements of
the Canadian Medical Devices
Conformity Assessment System
(CMDCAS) and (SOR/98-282)
and the key differences between
them and U.S. regulations.

5. Japan
Recognize the requirements of
the Japanese Pharmaceutical
Affairs Law (JPAL) for medical
devices.

6. Other international agencies
Recognize other international
agencies such as Therapeutic
Goods Administration
(TGA), State Food and Drug
Administration (SFDA) National
Health Surveillance Agency Brazil
(ANVISA), etc.

FDA Guidance for the
Manufacture of (IVD) Products

Explain how FDA guidelines for in vitro
diagnostic (IVD) devices are applied
to the current good manufacturing
practices (cGMPs). (Understand)
C. International Standards
for Quality Systems
1. ISO 9001, ISO 13485, ISO 17025
Evaluate the selection and use
of these various quality system
standards.