As a medical device consultant, with 20 years of industry experience, I felt that there was a need for a consultancy focused on providing quality services to the industry within the following areas: Audit, Training and PRRC.
I have worked with auditing throughout my entire career in medical devices, performing first, second and third party audits globally. Throughout all the years, I have seen that audits pose a challenge to the industry, but also provides a huge benefit when done correctly.
The challenge is that performing audits interfere with daily business, and it requires personnel to focus on something that is not usually their key interest or their core competency.
The benefit is that when done correctly audit can provide valuable information on the state of compliance of a company.
By using a medical device consultant for internal and supplier audits it is possible to fulfill your company’s audit requirements and obligations, and still keep the focus on the day-to-day business activities.
For the past couple of years I have been performing MDSAP audits for medium and large companies. For some clients it has unfortunately been a difficult challenge with a large number of non-conformities. Unfortunately, in some cases it has also meant loss of sales in Canada.
The audit method is not what most companies are used to. MDSAP is focused on identifying problem areas within the company. By having a Mock audit to the MDSAP requirements, performed by a qualified MDSAP auditor, you will be able to identify your issues before a certification or surveillance audit. You will also be able to gain valuable insights into handling any identified issues. This insight will improve your chances of a successful audit when that time comes.
When you have a Mock audit you are not obliged to tell your Notified Body about the outcome of the audit! This is however dependent on your not using it as documentation for your internal audit. This gives you an opportunity to identify and address issues prior to your MDSAP audit and not divulge any sensitive information.
The new European Medical Device Regulation 2017/745 (MDR) is entering into force soon (May 26, 2021). Many companies are unsure of whether their Quality Management System will meet the requirements of the regulation. Certification to the MDR is important, as it is key to being able to sell devices in the EU. Pre-assessment and Mock audit of your QMS prior to your certification audit helps you succeed.
Internal and supplier audits
It can be beneficial for companies to have an external resource performing supplier and internal audits. This reduces the challenges with both competence and impartiality. It can also add a focus to the audit that is usually not present.
For further information about 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.
Curriculum Vitae - Gert Sørensen
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