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Forcentis AG

Summary

About the company

The core activity of Forcentis AG is the provision of services in the field of quality management and risk-based qualification and validation in medical technology. The company supports manufacturers of medical technology products and their suppliers, as well as machine builders and plant manufacturers, in the development and validation of medical technology products and processes.

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Offering

Products & services

Industry:Technical Consulting & Engineering

✓ Offered6

Requirements Management

Requirements management, specification analysis and review, URS and functional specifications, traceability tables, mediation and requirement redefinition, design transfer and documentation.

Risk Assessment

Risk assessment, workshop preparation and moderation, process and equipment risk analysis, risk evaluation and mitigation, documentation and compliance with ISO 14971.

Validation

Equipment qualification (IQ/OQ/PQ), process validation, test method validation, revalidation and periodic review for regulated manufacturing environments.

Implementation

Manufacturing documentation, control plans and SOPs, test concepts and acceptance tests, design transfer execution into production.

Quality Management Systems (QMS)

Adaptation, maintenance and refinement of certified QMS, integration of new technologies, audit preparation, revalidation, periodic review and regulatory change management.

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Forcentis AG

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Forcentis AG

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