Services
We can help you with
Auditing
Audits are challenging for organizations, but Quality-Audit can help ease the burden, whether you are looking for a mock audit or wish to outsource your internal and supplier audits. With 20+ years of industry experience and Notified Body experience we have seen it all. Are you struggling with audit challenges? Book a video consultation, so we can address your needs and issues.
Consulting
Quality-Audit offers medical device consulting on compliance related tasks.
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. But sometimes things don’t go as planned – you may have had an audit or inspection that raised a lot of NCs or really complex NCs, or you may be facing an audit that you are worried about. In those cases Quality-Audit can assist you with:
- Remediation of Quality-Systems.
- Assistance with responses to NC’s and warning letters.
- Assistance during audits and inspections.
Training
Training is provided as:
- Mock Audits (probably the best training you can provide your employees)
- Auditor or regulatory training – bespoke and inhouse (MDR/MDSAP/ISO)
Inhouse training is more efficient – and more cost efficient – than external training. It provides more training to more employees for less money per capita
Read about the steps we can help you with
Idea
Failing to plan is planning to fail, so they say.
If you have got a new idea, it could be developing a new product, entering a new market or implementing new regulations then an early meeting with an auditor can help you in identifying challenges and avoiding pitfalls (regulatory requirements).
Design
Design in the medical device industry comes in a number different shapes; design of the QMS, design of process lines, design of products, etc.
Having the design audited early in the process provides the opportunity to adapt early, thereby ensuring more robust design output.
Manufacture
Once the product enters the manufacturing stage audits are an ongoing activity, and many companies face challenges around this. Either because they don’t have auditors who are qualified for the scope of activities, or because the auditors have to handle their full time jobs and also act as auditors.
Using external auditors can help you having qualified and flexible auditors at your disposal, whenever you need them.
Outsourcing you audits (internal or supplier audits) brings not only flexibility and higher competence levels to the audit, but also the added bonus of an auditor who sees many different companies throughout the year, and so can better gauge if your system can be improved.
Launch
Before the product can be launched audits are needed to ensure that all regulatory requirements have been met, and that market authorization is in place.
Audit prior to launch generally has to cover all aspects of the device being launched, and if it is your first product on the market then it has to cover the entire QMS, as it relates to the product. E.g.: for the first product on the EU market it has to cover ISO 13485:2016, EU MDR 2017/745 and the technical documentation.
Post-market
After product launch audits are needed to ensure that the manufacturer maintains a compliant QMS, and that is efficient in achieving its purpose.
Over a 2 year cycle (and risk based) the entire system is required to be audited, including technical documentation and all applicable regulatory requirements.
Outsourcing you audits brings not only flexibility and higher competence levels to the audit, but also the added bonus of an auditor who sees many different companies throughout the year, and so can better gauge if your system can be improved.
Idea
Failing to plan is planning to fail, so they say.
If you have got a new idea, it could be developing a new product, entering a new market or implementing new regulations then an early meeting with an auditor can help you in identifying challenges and avoiding pitfalls (regulatory requirements).
Design
Design in the medical device industry comes in a number different shapes; design of the QMS, design of process lines, design of products, etc.
Having the design audited early in the process provides the opportunity to adapt early, thereby ensuring more robust design output.
Manufacture
Once the product enters the manufacturing stage audits are an ongoing activity, and many companies face challenges around this. Either because they don’t have auditors who are qualified for the scope of activities, or because the auditors have to handle their full time jobs and also act as auditors.
Using external auditors can help you having qualified and flexible auditors at your disposal, whenever you need them.
Outsourcing you audits (internal or supplier audits) brings not only flexibility and higher competence levels to the audit, but also the added bonus of an auditor who sees many different companies throughout the year, and so can better gauge if your system can be improved.
Launch
Before the product can be launched audits are needed to ensure that all regulatory requirements have been met, and that market authorization is in place.
Audit prior to launch generally has to cover all aspects of the device being launched, and if it is your first product on the market then it has to cover the entire QMS, as it relates to the product. E.g.: for the first product on the EU market it has to cover ISO 13485:2016, EU MDR 2017/745 and the technical documentation.
Post-market
After product launch audits are needed to ensure that the manufacturer maintains a compliant QMS, and that is efficient in achieving its purpose.
Over a 2 year cycle (and risk based) the entire system is required to be audited, including technical documentation and all applicable regulatory requirements.
Outsourcing you audits brings not only flexibility and higher competence levels to the audit, but also the added bonus of an auditor who sees many different companies throughout the year, and so can better gauge if your system can be improved.
