ma meditec

ma meditec supplies the medical technology industry with production, testing and assembly systems for medical devices such as contact lenses, inhalers, insulin pens, auto-injectors and stents.

For these plants, ma meditec also offers qualification services (e.g. GMP documentation) and its own Lean Validation Concept in order to shorten the times for machine qualification and validation for its customers. Thus, ma meditec contributes to a shorter time-to-market and helps to reduce costs up to the market launch.

Individual process consulting, GMP-compliant design, comprehensive qualification experience coupled with the precise selection of suitable technology and our system partners ensures decisive added value for our customers.

The quality management system of MA micro automation GmbH 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

Supported through MA micro automation GmbH

We provide you support with defining your requirements, risk assessments, system configuration, testing, service and maintenance. Meeting the expectations of regulated companies in the medical and pharmaceutical industry is our primary objective.

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) 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.

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