I have just started a new job and have been tasked with establishing and implementing ISO 13485 for Biomaterial Product line used as components for medical devices. We do a great deal of design & development for implantables. I have reviewed some of the company's DHF that are compliant with ISO 9001. Is there any additional information I need to include in the future for ISO 13485? Do I need to go back and update any of the past files for components to be marketed under the ISO 13485 registration? As a contract manufacturer of components for medical devices, what level of risk management are we responsible for?
Recommendations welcome!
Hi Wisdomseeker,
If your company is designing and manufacturing FDA Class III medical devices as a contract manufacturer, you're subject to the FDA establishment registration requirements. If you're selling the product internationally, you'll need to conform to the requirements of the appropriate Directive or legislation for licensing and distribution of medical devices in their countries. Depending on the country, there may be additional requirements and/or labeling.
13485 places a greater emphasis on documentation requirements, especially in the areas of verification, validations, clinical trials, risk management, etc. Below are the differences between ISO 9001:2000 and 13485:2003 for design and development.
7.3.1 Design and development planning
The organization shall establish documented procedures for design and development.
Planning output shall be documented, and updated as appropriate, as the design and development progresses (see 4.2.3).
NOTE Design transfer activities during the design and development process ensure that design and development outputs are verified as suitable for manufacturing before becoming final production specifications.
7.3.2 Design and development inputs
Inputs relating to product requirements shall be determined and records maintained (see 4.2.4).
These inputs shall include
a) functional, performance and
safety requirements, according to the intended use,
e) output(s) of risk management (see 7.1). These inputs shall be reviewed for adequacy and approved.
7.3.3 Design and development outputs
Records of the design and development outputs shall
be maintained (see 4.2.4).
NOTE Records of design and development outputs can include specifications, manufacturing procedures, engineering drawings, and engineering or research
logbooks.
7.3.4 Design and development review
Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed, as well as other specialist personnel (see 5.5.1 and 6.2.1).
7.3.6 Design and development validation
Design and development validation shall be performed
in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified
application or intended use. Validation shall be completed prior to the delivery or implementation of the product (see Note 1).
Records of the results of validation and any necessary actions shall be maintained (see 4.2.4). As part of design and development validation, the
organization shall perform clinical evaluations and/or evaluation of performance of the medical device, as required by national or regional regulations (see Note 2).
NOTE 1 If a medical device can only be validated following assembly and installation at point of use, delivery is not considered to be complete until the product has been formally transferred to the customer.
NOTE 2 Provision of the medical device for purposes of clinical evaluations and/or evaluation of performance is not considered to be delivery.