Validations/Qualifications

• Creation of validation master plans, user requirements, specifications and requirements documents
• Creation and planning of all necessary documents for validation of processes (design, installation, functional and performance qualifications) including support before, during and after implementation
• Integration of the validation process into the existing quality management system
• Interpretation of validation according to requirements of ISO 13485 and the American regulation 21 CFR 820 (GHTF-IMDRF)

For internal and external audits

Carrying out internal and external system or process audits to verify compliance with ISO 13485 / ISO 9001 standards or independent audits of internal workflows and processes according to the client’s specifications.

Risk management

• Support in the preparation of risk assessments according to ISO 14971
• Establishment of risk management and integration into an existing quality management system

Project management

• Implementation of projects with a technical background (e.g. development projects, production relocation, etc.) in various areas
• Planning and organizing complex tasks
• Compliance with targets and budgets as specified and agreed with the responsible management

Medical Device Regulation (MDR)

Medical Device Regulation (MDR) – Implementing requirements in the quality management system (QMS) 2019, TÜV Süd Akademie, Munich

Contents:

Regulatory basis in the MDR
Impact on economic actors in Europe

Necessary contents of a QMS compliant with MDR
Impact on the QMS compared to ISO 13485

Need for updates and changes in the QMS

New elements in the QMS

• Scope, liability aspects, responsible person, registration of products and economic actors
• Labelling and instructions for use, promotional material, information, implantation card
• Post-market surveillance – monitoring after the product has been placed on the market
• UDI – Unique Device Identifier, EUDAMED, practical implementation

ISO 13485 / ISO 9001

ISO 13485 Update Training 2016, TÜV Süd Academy, Munich

Contents:

• ISO 13485 compared to ISO 13485 and ISO 9001
• Regulatory requirements
• Process risk management in the company
• Process risk management for outsourced processes and suppliers
• Quality management after placing medical devices on the market (post-production)
• Design and development: validation, verification and design transfer
• Software validation

Risk management for medical devices

Risk management and risk analysis for medical devices according to DIN EN ISO 14971:2012 – 2015, TÜV Süd Akademie, Munich

Contents:

• Applicable standards
• Definitions
  • Risk analysis
  • Risk management
  • Risk analysis procedures
  • Risk assessment
• Carrying out risk analysis; risk assessment
  • Estimation of extent of damage
  • Estimation of probability of occurrence
• Examples of form and documentation
• Role of risk analysis in the design process
• Impact of risk analysis on the QM system

Process validation for medical devices

Process validation for medical devices – 2015, TÜV Süd Academy, Stuttgart

Contents:

• Basics of process validation
• Overview of the current status of standardization (ISO 13485, 21CFR820)
• Definition (VMP, IQ, OQ, PQ)
• Integration of risk management according to ISO 14971
• Risk-based sampling plans based on LTPD and AQL
• The documentation practice
• Validation change management
• Statistical evaluation of results
• Summarizing validation reports

CAPA

CAPA – 2015, TÜV Süd Academy, Munich

Contents:

• Basics for Corrective and Preventive Actions (CAPA) from ISO 13485 and 21CFR820
• Differences between correction, corrective action and preventive measure
• Components of a CAPA system
  • Determine the actual scope of the problem
  • Determination of causes and detection methods
  • Transparent planning of corrective and preventive measures
  • Effective implementation
  • Objective success control
• Workshop Root-Cause-Analyse
• Expectations of documentation
• Risk-based monitoring and escalation
• CAPA Trigger

Management systems in the medical device sector

Management systems in the field of medical devices – 2015, TÜV Süd Academy, Munich

Contents:

• Basics of implementing management systems for medical device manufacturers
• Overview of the current state of standardization
• Application and validity of ISO 13485
• Links with international regulatory requirements
• Structure and contents of ISO 13485
• Key points of implementation
• Differences to ISO 9001