Get proof of your competence.

Shall have performed at least 6 (six) quality system audits where at least 3 (three) shall be external (e.g. supplier audits) OR you shall have performed at least 10 (ten) internal audits. These audits shall in total have covered all applicable requirements in relevant standards/regulations. These audits shall have covered document review, preparation, on site audits and audit reporting. 1 (one) audit consists of 8 (eight) hours on site audit. At least 70% score in the examination test consisting of 2 parts. One part is related to Auditing as per ISO19011 and one part is area specific Regulatory requirements, either Pharmaceutical or Medical Devices.

In addition to the required experience and competence for Auditor, a Lead Auditor shall have additional knowledge and competence to be able to lead and coordinate a team of auditors. To be certified as Lead Auditor you shall, in addition to have passed the theoretical exam, have the same experience as required to be Auditor (as above), also have worked in a team coordinated by another Lead Auditor and have performed at least 4 (four) quality system audits (internal or external) as Lead Auditor and have coordinated a team of at least one additional person.

We invoice companies, 30 days net. For private individuals we require credit card payment in advance. NOTE: For private individuals a 25% VAT (tax) is added.

The tests are available in English.

At this time QA/RA Leader, Auditor Pharmaceutical, Auditor medical device etc (total 3), but we are working on expanding the range.

It depends on the certification. Download the specifications for each certification.

The person’s knowledge of the regulatory requirements within the medical device industry is crucial to establish whether or not the candidate is qualified as a QA/RA Leader Medical Devices. The following theoretical and practical requirements should, at the very least, be met, in addition to an approved certification exam in order to obtain a certificate. Alternative 1) Completed university degree or equivalent education within science, medicine, pharmacology, engineering or other relevant subject and at least two years’ professional work experience in the areas of Regulatory or Quality Management systems in relation to the medical device industry. Alternative 2) Five years’ professional work experience in the areas of Regulatory or Quality Management systems in relation to the medical device industry. Alternative 3) At least two years’ professional work experience and completed relevant education in the areas of Regulatory or Quality Management systems in relation to the medical device industry.