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Being compliant is not a fixed state that a company that produces medical devices finds itself in, as there are often new requirements that the company must adapt to. Compliance can have two meanings, as it is both something the company can do and can become. A company that produces medical devices becomes compliant when it complies with a number of different legislations, where the number and complexity of the regulatory requirements have increased significantly in recent years. This is done by setting clear guidelines for how compliance must be achieved.
The first step in compliance is for the company to determine which laws fall within the company’s area. The second step is that the company must plan, organize and draw up internal guidelines for how it must be able to comply with these rules. Popularly speaking, compliance is an umbrella term that covers the entire process of how a company handles the rules that apply to it.
AL Engineering A/S has extensive experience in advising pharmaceutical companies with the determination and implementation of relevant compliance policies and compliance programs.
By ensuring a good environment in production, a good delivery of high-quality products is ensured. Our experience with controlled environment and cleanroom validation extends from very small cleanrooms with a single sluice, to large complex facilities of several thousand m2 with class B, C, D and CNC, UDF solutions for class A areas above machines, and sluices with PLC interlock systems for separating the different classes. Our specialists have more than 20 years of experience with environmental monitoring and validation of cleanrooms. Use their experience to ensure a controlled production environment in
The Medical Device industry is regulated by ever-increasing compliance/authority requirements. The increasing requirements aim to strengthen patient safety and to ensure sufficient availability of medical devices, which i.a. is based on a risk-based approach. The goal is that patients are better protected in all respects. We can offer help in managing risk management for medical equipment. We have a detailed knowledge of the analysis techniques FMEA/FMECA and HAZOP and have extensive experience with planning and implementation using the mentioned techniques as well as reporting risk analyses.
When developing a medical device, there are a number of regulatory requirements that must be met before the product can be introduced on the market. At AL Engineering, we offer regulatory advice as well as help with the preparation and maintenance of documentation according to applicable authority requirements, e.g. MDR 2012017/745, CE marking and relevant standards. Developing IEC 62304 compliant software for medical devices can be a big challenge. In addition to the software being developed for a special user purpose, it must also meet the requirements of ISO 13485, ISO 14971, and IEC 62304 standards. Our partner and specialists have extensive experience in developing SW as a medical device up to Class II b which is approved by the authorities and introduced on the market.
We carry out qualification and validation of production facilities and production equipment for the production of medical devices based on a risk-based approach. We prepare validation plans, requirement specifications, test plans, test protocols and reports (DQ, IQ, OQ, PQ, and PPQ) and carry out FAT/SAT etc. as well as deviations and change control.
Our partner has developed software for Skin Analytics, whose mission is to help more people survive skin cancer.
AL Engineering A/S
Tuse Næs Vej 7C
DK-4300 Holbæk
Phone +45 59 45 13 68
Email: info@al-engineering.dk
VAT: 25730011