Medical Devices

QCL_blau_transparent V2 provides services and support for medical device manufacturers and their suppliers for the identification of and compliance with regulatory requirements related to  

Quality Management

Bild2 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

Bild2 Interim Quality Management Representative with full responsibility for implementation, maintenance, and monitoring of required processes

Bild2 Preparation and Implementation of quality programs, quality circles, and management reviewss

Environmental Management

Bild2 Remediation and Implementation of Environmental Management Systems according to EN ISO 14001

Bild2 Interim Environmental Management Representative with full responsibility for implementation, maintenance, and monitoring of required processes

Bild2 Preparation and implementation of environmental targets

Bild2 Installation of an integrated management system for process-oriented control of quality and environmental objectives

Process Analysis / Audits

Bild2 Auditing of quality management systems according to EN ISO 9001, EN ISO 13485, 21CFR820, and GMP

Bild2 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

Bild2 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)

Regulatory Affairs

Bild2 Medical device submissions – international market approvals

Bild2 Communication with competent authorities

Bild2 Technical documentation according to MDD 93/42/EWG, FDA‘s 21 CFR 510(k), STED, and CSDT

Risk Management

Bild2 Risk Management for medical devices according to EN ISO 14971

Bild2 Creation / remediation of risk management file as a part of the technical documentation / STED file

Bild2 Installation / support of RM team regarding the control of RM processes and their interfaces

Bild2 Verification via safety test for electrical medical devices according to IEC 60601

Bild2 Validation via usability analysis according to IEC 62366

Bild2 Validation via clinical evaluation according to MEDDEV 2.7.1

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