Since the publication of the 2007/47 European Directive revising the 93/42 Directive, software has become of increased concern. In the same way, the US FDA has established since long key regulations on software when used with a medical device or for performing medical activities.
Software validation is necessary during the design, the manufacturing and the use of a medical device. In the essential requirements of the European 93/42 directive, it is specified that all medical devices that incorporate a software shall be validated in accordance with the state of the art. In the US, the CFR §820.70(i) states that automated process in production shall be validated.
In 2010, the FDA sent numerous warning letters to companies failing to demonstrate the validation of the software used on production process.
As a summary, shall be validated:
- All medical devices which incorporate a software (i.e. firmware)
- All medical devices which are operated by a software (i.e. GUI)
- All software used in a validated production process
- All software used for quality management related to medical devices (DMS, ERP, AOI, etc.)
This also includes traditional spreadsheets including QC acceptance formulas. In order words, few medical devices manufacturers are freed from software validation.Medídée is experienced in the validation of software for all the above mentioned configurations. Wether incorporated in a medical device or used during the production process, we support simple and efficient validation processes based on the latest international standards. Through a risk-based approach we helép identifying hazard that may result in potential product or system defect or patient injuries.
Thanks to our multidisciplinary team, we provide the necessary competences and a safe project approach.
Our software services
Support / realization of the User Requirement Specification
- Medical device design validation and design transfer for manufacturing
- Validation of software for automated equipment
- Validation of software for monitoring and measuring devices
- Validation of ERP, Document Management Systems, etc.
- Validation of Systems used for Quality Management
- Computer systems and medical device software validation
- Laboratory equipment qualification
- Preparation and documentation of the Validation Plan and the tests protocols
- Realization of the operational and performance test
- Review of the User Documentation (IFU)
- CFR 21 Part 11 gap analysis
- ISO 13485:2003 software requirements gap analysis
For more information on software validation, please send us a message through our contact form and we will contact you within no time.