provides services and support for medical device manufacturers and their suppliers for the identification of and compliance with regulatory requirements related to
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 reviewss
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
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
Process analysis with recommendations for corrections and corrective actions (CAPA)
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
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
