ryno fan,
As the prior posts indicated, software is certainly considered a component of a medical device (or a medical device on its own, as applicable) and therefore requires the same controls as applied elsewhere in your company for your medical device.
The control of the raw material/component, in your case outsourced software or software modules/ assessments, would fall under your general purchasing controls. The primary standards for software control would be defined within the FDA Harmonized standard ISO 62304, and the general principals of software validation guidance from the FDA, GHTF and other agencies, as applicable. Some of the ones I have utilized in the past few years include:
? 21 CFR 820.30, Quality System Regulation, Design Control
? Design Control Guidance For Medical Device Manufacturers (March 11, 1997),
General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11, 2002
? Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff (05/11/2005)
Guidance for Off-the-Shelf Software Use in Medical Devices (09/09/1999)
? Applicable EU directive (i.e. 90/385/EEC Council Directive of June 20, 1990 relating to active implantable medical devices ? Active Implantable Medical Device Directive (as amended by directive 2007/47/EC, 21-Sep-2007, and previous)
? EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
? ISO 14971:2007 ? Medical devices ? Application of risk management to medical devices
? EN 60601-1:2006/AC:2010 for Programmable Medical Software (?14)
? IEC 62304:2006 Medical device software ? Software life cycle processes
I would ensure that your supplier controls for the subcontractor are well defined. You may want to consider reviewing Appendix 2 of Guidance for Notified Bodies Auditing Suppliers to Medical Device Manufacturers for some important considerations to include in your contract with the outsourced partner that may help demonstrate adequate control during your next audit.
Raw material and software is also mentioned in the preamble for the QSR as a component. Anyway, just my
