It is vital to ensure that your medical devices will meet the standards required by the health authorities responsible in the country you wish to market your device.
dicentra can provide you with an independent audit of the following standards and systems, in order to help you ensure your medical devices are compliant.
QMS Audit
A Quality Management System (QMS) for Medical Devices documents and specifies processes, policies and procedures, and responsibilities required to ensure the quality of the device.
The quality standard recognized internationally for a Medical Device is the ISO 13485:2016 standard, however in the United States, the FDA Quality System Regulations and FDA 21 CFR Part 820 identify the quality standards by which medical devices must comply.
dicentra can provide you with an independent QMS audit and assessment against all the applicable standards including ISO 13485, the FDA QSR, and FDA 21 CFR Part 820 (CGMP’s).
ISO 13485 Audits for Medical Devices
In order to maintain compliance with your medical device Quality Management System in Canada and in Europe, you must meet the ISO 13485 standard. While a manufacturer can perform its own internal audit under ISO 13485, an independent audit by dicentra can provide an unbiased and more objective assessment of the status of your QMS.
dicentra’s services in third party ISO 13485 standards include:
- Off site (desk) review of your QMS against ISO 13485 standards
- Review of records and documentation
- On-site inspections prior to regulatory audits
- On-site inspections for compliance against ISO 13485 standards
- Analysis of current QMS with recommendation
MDSAP
The Medical Device Single Audit Program is a globally recognized auditing and monitoring program recognized in Canada, United States, Brazil, Europe, Australia, and Japan, among many other affiliated members. In Canada, as of January 1, 2019, companies who wish to sell their Class II, III, and IV medical devices must be able to demonstrate that their medical devices are compliant to ISO 13485 under the Medical Device Single Audit Program (MDSAP).
dicentra can audit your quality system to prepare you for MDSAP and ensure you are compliant.
Third-party CGMP Audit
In order to meet ISO and FDA standards for medical device quality systems, medical device manufacturers are required to meet the current Good Manufacturing Practices or CGMPs. A third-party CGMP audit can help identify quality issues before they lead to non-compliance.
dicentra’s services in third-party CGMP auditing include:
- Conducting CGMP audits (domestic and foreign sites)
- Review of records and documentation
- On-site inspections prior to Regulatory audits
- On-site inspections for compliance with the appropriate regulations
- Analysis of current systems with recommendations
Contact our medical device specialists using the form below to learn more about our medical device auditing services