Medical device – Reference
AL Engineering has worked with a wide range of companies in the pharmaceutical industry and subcontractors.
Gap analysis of existing Medical device production in Denmark and Switzerland.
Purpose: Identifying potential compliance validation gap’s.
Result: Development of a new optimized validation system, and re-validation of all processes and equipment based on a risk based approach.
Audits and Quality Agreements
Supplier audits and approval’s in China, Europe and US based on ISO 9001, ISO 13485 and 21 CFR part 820.
Development of Quality Agreement with suppliers.
Preparation of requirement specifications for different customers
Design and Production Audits
Deep dive audits with focus on tractability in design control and production documentation for a Medical Device company in Denmark, in relation to inspection readiness.
Training and documentation
Training of employees in Risk, URS, GxP, validation and provide templates for customers.
Risk analysis of production facilities
Risk analysis performed for different customers.
Supervision, coordination and control of suppliers.
Validation of computerized systems
Validation of computerized test equipment.
Purpose: identifying gap’s and level of validation and perform validation of the test equipment.
Result: Validation of computerized test equipment and subsequently received audit without comments.
Project management / coordination of computerized validation
Validation of computer-controlled equipment for medical devices companies
Implementation of quality system
Development of QMS system based on ISO 13485 for sales and distribution companies globally.
Project management / coordination of projects for medical equipment companies
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