The best medicine:
ma meditec supplies the medical technology industry with production, testing and assembly systems for medical devices (e.g. contact lenses, diagnostic consumables, medical injection moulding components, insulin pens, auto injectors as well as pipette tips and reaction tubes).
For this, many large and small qualification services (e.g. GMP documentation) are offered, in order to shorten the times for machine qualification and validation. Thus, ma meditec contributes to a shorter time-to-market and helps to reduce costs up to the market launch.
The big plus for our customers: Individual process consulting, GMP-compliant design, comprehensive qualification experience coupled with the suitable technology and our handpicked system partners.
The quality management system of MA micro automation is certified according to ISO 9001:2015 and is based on GMP guidelines.
The certificates can be found under Downloads.
GMP with
MA micro automation GmbH
Strong support for our customers
We provide you support with defining your requirements, risk assessments, system configuration, testing, service and maintenance. Our primary objective: Meeting the expectations of regulated companies in the medical and pharmaceutical industry.
For the qualification activities we follow the V-model.
Qualification documentation
The specifications, tests and proofs required for qualification are agreed with the customer in a specification and test plan and are carried out either at our or at the customer’s premises.
With the system developed, manufactured and delivered by us, we then provide you with the required documents for qualification (DQ, IQ, OQ, PQ) and support you with the validation.
Machine qualification
The necessary tests for the qualification are coordinated in a test plan with the customer in accordance with VMP (validation master plan) and are carried out in-house or at the customer’s site.
