The AL Engineering A/S Medical Device Business unit offers consultancy and support to the Medical Device industry. The services are offered broad to both Danish, Scandinavian and international based Medical Device companies.
The Medical Device industry are facing massive changes these years due to updates and implementation of regulations and guidelines from e.g. the European Health Authorities. The requirements to the whole Medical Device industry are therefore elevating with the implementation of MDR2017 and ISO13485:2016 which both will be significantly tightened in relation to compliance.
The competencies at the AL Engineering consultants are therefore aiming against compliance with the new requirements from the FDA and EMA authorities.
The core competencies in relation to Medical Devices covers
- Compliance related tasks according to current valid regulations and guidelines.
- Process validation
- IT/SW validation
- Project management related to compliance, optimization, and implementation of new machines and processes
- Securing the appropriate quality and compliance level
- GAP-analysis related to current regulations and requirements
- Mock Audits and pre-audit assessments
- Qualification of cleanroom and related facilities (environmental monitoring)
In addition to this the AL Engineering Medical Device area collaborates with various partners who assist with their specific Medical Device related competencies.
Please contact Medical Device, Tina Linders for a non-committal talk about how we can make a difference for your company. Mobile: 2913 2445, Mail: firstname.lastname@example.org