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We offer specialists with competences within quality assurance who can assist with support for the following tasks:
It can be a great advantage to use electronic systems for handling QA documents, procedures and not least the training part. Regardless of whether you use a manual or electronic system, we have extensive experience in building and implementing systems for quality assurance.
The European medical device directive MDR 2017/745, which were implemented in May 2021, entailed significant regulatory changes which had a major impact on various areas of an organization. We are fully up to date on MDR and understand the differences between MDD and MDR. Our experience with MDD means that we are able to assess the implementation of MDR and can support in preparing a plan for a successful transition.
In order to be able to market a medical device within the EU, the manufacturer must, as a starting point, ensure that the medical device is CE-marked. The CE marking is the manufacturer's documentation that the equipment meets the applicable EU legislation. We can support with which requirements must be met, what is relevant and how the documentation is designed so that it complies with the legislation. Our regulatory experts can support or prepare the technical file.
An internal audit is the company's own assessment of the effectiveness of the management system. The more impartial an internal audit is, the greater its value. It can therefore be an advantage to choose a consultant from AL Engineering to carry out an audit, as the result will often be more useful and constructive. In addition to internal audits, we also have extensive experience in planning and carrying out external audits of approved critical suppliers and/or business partners both nationally and internationally.
AL Engineering A/S
Tuse Næs Vej 7C
DK-4300 Holbæk
Phone +45 59 45 13 68
Email: info@al-engineering.dk
VAT: 25730011