Based in Denmark Quality-Audit is a privately owned company. It is owned and operated by Gert Sørensen (LinkedIn profile), and provides independent, professional and discreet consulting services for the medical device industry. Whether your company is a start-up or a global company Quality-Audit is able to help, both on-site and remote.
Audit
- Remote audit.
- Mock audit.
- Supplier and Internal audit.
- Outsourced audit.
- Due Diligence audit
Consulting
- Remediation of Quality-Systems.
- Assistance during audits and inspections.
- Assistance with responses to NC’s and warning letters.
PRRC
Person Responsible for Regulatory Compliance for small manufacturers and EU authorized representatives.
Gap-assessments
Pre-audit assessments to help you identify gaps in relation to requirements from standards and regulations. E.g. ISO 13485:2016, MDSAP, MDD, EU MDR.
Downloads
Click here to access Quality-Audits downloads.
During the last few years the industry has already had to adjust to the updated ISO 13485 standard, and for many also to the MDSAP requirements. Now the industry moves from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR), and it is important to understand the implications on the quality management system (QMS), however it may be quite challenging to not only identify gaps and necessary actions to comply with the new MDR, but also to evaluate if the actions taken are sufficient to maintain compliance with European medical device requirements. Quality-Audit provides medical device audits and consultancy globally – on-site or remote – that can help to support you through this transition.
As a manufacturer of medical devices the purpose of your Quality Management System is to ensure that the device will be developed, tested, manufactured and documented in accordance with general rules like MDR 2017/745, 21 CFR 820 and ISO 13485:2016, and to ensure that devices marketed is safe for end users, and will be effective in the treatment for which they are used. Independent and thorough audits and consultancy can help improve and enhance your system.
For further information on how Quality-Audit can help you with your current medical device compliance challenges please use the contact form, or call for an informal discussion on +45 31 44 40 24.