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Quality Management of Medical Devices

QC Loop provides full support in Quality Management and services for the identification of applicable standards and compliance with self-defined and regulatory requirements for manufacturers of Medical Devices and their suppliers in the following areas:

Quality Management, Environmental Management, Process Analysis / Audits, Regulatory Affairs, Risk Management

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Quality Management

  • Remediation and Implementation of Quality Management Systems according to EN ISO 9001, EN ISO 13485, 21 CFR 820, CMDCAS, JPAL, and Resolution No.59 or internationally applicable GMP requirements

  • Interim Quality Management Representative with full responsibility for implementation, maintenance, and monitoring of required processes

  • Preparation and Implementation of quality programs, quality circles, and management reviews
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Environmental Management

  • Remediation and Implementation of Environmental Management Systems according to EN ISO 14001

  • Interim Environmental Management Representative with full responsibility for implementation, maintenance, and monitoring of required processes

  • Preparation and implementation of environmental targets

  • Installation of an integrated management system for process-oriented control of quality and environmental objectives
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Process Analysis / Audits

  • Auditing of quality management systems according to EN ISO 9001, EN ISO 13485, 21CFR820, and GMP

  • Preparation, attendance, and wrap-up of certification, re-certification, and surveillance audits as well as country specific FDA inspections (CFDA, SFDA, KFDA etc.), ANVISA, JPAL, and CMDCAS inspections

  • Preparation and performance of internal audits and supplier audits according to EN ISO 19011 Bild2 Process analysis with recommendations for corrections and corrective actions (CAPA)
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Regulatory Affairs

  • Medical device submissions – international market approvals

  • Communication with competent authorities

  • Technical documentation according to MDD 93/42/EWG, FDA‘s 21 CFR 510(k), STED, and CSDT
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Risk Management

  • Risk Management for medical devices according to EN ISO 14971

  • Creation / remediation of risk management file as a part of the technical documentation / STED file

  • Installation / support of RM team regarding the control of RM processes and their interfaces

  • Verification via safety test for electrical medical devices according to IEC 60601

  • Validation via usability analysis according to IEC 62366

  • Validation via clinical evaluation according to MEDDEV 2.7.1
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