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Quality Management Systems
European and Canadian Quality Management Systems
 Staff and management training on the requirements of ISO 13485
Conducting internal audit and designing effective corrective action plan
Assisting in the implementation of corrective audit plan
Implementation of Risk Management Procedure in accordance with ISO 14971
Implementation of Usability Files in accordance with EN 60601-1-6 and EN 62366
Development of an effective corrective and preventive action system (CAPA system)
US Quality System Regulation (21 CFR § 820)
Staff and management training to the requirements of quality system regulations (QSR)
Development of an effective Corrective Actions and Preventive Action systems (CAPA system)
Implementation of an effective Hazard Analysis and Critical Control Points (HACCP) program
Process validation, including facility master plans and assistance in the development of procedures,
protocols and reports, In process-controls and sampling, Failure investigation
Supplier Assessments
Established a documented supplier evaluation and surveillance system
Conducting audits of suppliers of products and services as part of the FDA and European
quality systems requirements
Assist suppliers in meeting quality requirements
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VISAMED Consulting Services for Medical Industries Tel. +49(0)721-4764847Mail |
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