iMDPC GmbH is a leading company in the field of quality management according to ISO 13485:2016, US QSR and MDSAP. We offer comprehensive services such as implementation, maintenance and auditing of the quality management system. Our expertise also includes strategic consulting for the approval of medical devices, technical documentation and project management. With our international network and many years of experience, we are your reliable partner. Our services include, among others:
Quality Management
Coaching, implementation, maintenance of the quality management system according to ISO 13485: 2016, US QSR and MDSAP
Ready-to-use QMS documentation according to ISO 13485: 2016
Carrying out internal audits
Process analysis and implementation of process optimization
Accompanying external audits (e.g., Notified body) and inspections(e.g., Competent Authority, FDA)
Regulatory Affairs
Strategic consulting and project management for the approval of medical devices (CE certification, US FDA and international product registrations)
Preparation of technical documentation and submission documents for international registrations
Project Management
Test strategies for non-active Medical Devices (Design Verification and Validation, Biocompatibility, Microbiological Status, Cleaning and Sterilization Methodology, ...)
Assistance in the realization of clinical evaluations
Planning and support in conducting process validations
Preparation of technical documentation and submission documents for international registrations
Support in the selection of laboratories in the context of developments, approvals of medical devices and validation projects
Factory Building - Planning and Responsibility for Bringing into Service
Complete supply chain for production, clean room construction, logistics, up to the construction of an international sales.
Cleanroom solutions ready for use, including all required qualifications and validations, ready for certification
Interim General Manager
Responsible for budget, training, schedules, responsible planning and realization
Contact for owners, suppliers, customers
Recommendation of suitable machinery, cost reduction through networking
Global Networking
With more than 200 international customers and suppliers as well as many years of international experience, imdpc is well connected internationally.
Multilingualism
German, English, Turkish, Thai, Mandarin
Contact details
iMDPC GmbH Am Freizeitzentrum 23 D-78194 Immendingen
