MDR Transition with PRRC-Function

• PRRC according to Article 15 MDR 2017/745
• Lead MDR transition for legacy products
• Communication with the notified body DQS
• Lead technical documentation
• Strategy in activities under MDR 2017/745
• Topics from the development department
• Risk management according to ISO 14971:2019
• Compliance and regulatory consulting for management/board

• Integrate CMI QMS of Dresden (HMDD) and Hradec Kralove (HMHK) with the global QMS of HMC

Work Package 1: Document Mapping

• Map and understand current QMS structures (CMI QMS and GQMS)
• Map CMI QMS docs to HMC global QMS docs
• Identify site-specific docs
• Create GHMC docs for missing CMI docs and tag obsolete CMI docs
• Update GHMC docs for similar but incomplete CMI docs and tag obsolete CMI docs
• Tag obsolete CMI docs when equivalent and complete
• Update references with new GHMC numbers

Work Package 2: Adoption of GHMC QMS documents into CMI sites

• Triage CMI documents to replace with GHMC documents
• Map CMI QMS docs to HMC global QMS docs
• Create DCRs for new and updated GHMC docs and obsolete CMI docs
• Include associated CMI docs in DCRs for reference updates

• Creation of the validation master plan
• Creation of the validation concept
• Creation of document templates: DQ, IQ, OQ, PQ, VP, VR
• Support of validation and creation of the final report
• Creation of the validation plan for class 2a products in the PDT area
• Creation of the risk analysis
• Coordination of preliminary qualification
• Evaluation of cleanroom concept for implementing 2a products
• Concept for cleaning processes in the cleanroom for medical devices
• Concept for manufacturing processes in an ISO class 7/8 cleanroom
• Consulting on biological safety requirements of the medical device
• Risk management documentation
• Technical documentation concept according to EU MDR 2017/745
• Evaluation of existing medical devices regarding EU MDR 2017/745 and basic requirements
• Review and approve documents in Develop D3

• Responsibility and leadership of quality management according to ISO 13485 and ISO 9001
• Additional responsibility under GDP for pharmaceuticals
• Audit management
• Compliance
• Team leadership with 4 employees
• Risk management according to ISO 14971
• Technical documentation
• Supplier management and audits
• CAPA and complaint management
• Communication with authorities

• Founded the company
• Quality management for medical device approval
• TQM auditor ©: 478 supplier audits, 13 FDA inspections
• Supplier quality engineering / supply chain process
• Optimizing and redesigning processes
• Implementation and rollout of quality management systems as project manager
• Conducting audits (e.g., supplier audits)
• Validation of sterilization processes / packaging
• Document management

Clients:

• B.Braun Melsungen AG, Melsungen (DE)
• B.Braun Medical AG, Sempach (CH)
• Schott AG, Mainz
• Brainlab AG, Munich
• Nicolay GmbH, Nagold
• Normed Medizintechnik GmbH, Tuttlingen
• Thales Deutschland GmbH, Stuttgart
• Henke–Sass–Wolf GmbH, Tuttlingen
• Klinikum des Landkreises Tuttlingen ZSVA
• Novartis Pharma AG, Basel
• Synthes GmbH Solothurn

• Setting up, changing over, and monitoring packaging, production, and labeling machines for the manufacture of cosmetic and technical products
• Responsible for liquid filling operations and aerosol technology in a regulated pharmaceutical environment
• Qualification and validation of electronic controls
• Quality management
• Personnel management
• Installation of electrical systems