We can help you achieve a certification for your ISO
13485 Quality Management System Designed for Medical Devices
and Products
ISO 13485 Certification |
Internal Auditing Services |
Internal Auditor Training
Services Available:
- Assistance with preparing for the
Certification Process and Audit
- Consulting and Guidance for ISO 13485
from Experienced Professionals
- Documentation
- Internal Auditing
- Internal Auditor Training
- Quality Management Software (QMSCAPA)
- Remote Implementations (saves time and
money)
- Risk Assessment assistance and Risk
Assessment Training
- Training to Requirements of the Standard
This standard is a technical specification applicable to the
quality management systems for the design, development,
installation, production and servicing of medical devices. For the
purpose of this standard a medical device, as described in the
European Medical Directive is:
“… any instrument, apparatus, appliance, material or other article,
whether used alone or in combination, including the necessary
software for its proper application, intended by the manufacturer to
be used for human beings for the purpose of:
-
Diagnosis, prevention, monitoring, treatment, or alleviation
of disease
- Diagnosis, monitoring,
treatment, alleviation of or compensation for injury or handicap
-
Investigation, replacement or
modification of the anatomy or of a physiological process
-
Control of conception
And which does not achieve its principle intended action in or
on the human body by pharmacological, immunology or metabolic
means, but which may be assisted in its function by such means
…..”
- ISO 13485 is based on the ISO 9000 process model
- Class 1 devices – Generally require just internal control of
production and compilation of a technical file. ISO 9000
satisfies this requirement. The technical file may be viewed by
a Competent Authority
- Class 2a devices – Require a quality management system to ISO
9000 + ISO 13485 and a technical file. Needs audit by a Notified
Body
- Class 2b devices – Requires a quality management system to ISO
9000 + ISO 13485 and compilation of a technical file to include
design. The final step is audit by a Notified Body
- Class 3 devices – Being the highest risk devices, it is
necessary to implement a quality management system to ISO 9000 +
ISO 13485 and compilation of a designer dossier which is a more
detailed Technical File. The final step is audit by a Notified
Body
- There are other conformance routes covering Own Brand labeling
and System and Procedure Packs
- A risk management process, such as ISO 14971, including hazard
analysis and risk control is required
- An Authorized Representative in Europe is required for
products produced outside Europe; must have possession of
Technical File.
- European distributors often act as an Authorized
Representative; independent companies also serve a roll when
companies have multiple distributors
- Registration with the Competent Authority of the country in
which the product will be made available is a requirement.