Consulting, quality, success

network for quality

Consulting, Quality, Success

Network for Quality

networQuality

Consulting in Medical Technology

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Validation/Qualification
  • 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)
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
Medical Device Regulation

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 13485:2016

Need for updates and changes in the QMS

New elements in the QMS

  • Scope, liability aspects, responsible person, registration of products and economic operators
  • 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
Risk Management

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
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
Internal/External Audits

Conducting internal and external system or process audits to verify compliance with ISO 13485 / ISO 9001 standards or independent audits of internal workflows and processes as specified by the client

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
ISO 13485 / ISO 9001

ISO 13485:2016 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
Process validation

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
Management Systems

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
QM Systems
  • Establishment, further development and maintenance of internal or external processes to comply with applicable regulations such as ISO 13485, 21 CFR 820 and MDR.
  • Support in setting up QM systems and necessary documentation according to GDP (Good Documentation Practice) specifications.
  • Creating, developing and revising process and work instructions.
  • Gap analyses of applicable regulations to revise existing documentation.
Production Technologies

PRODUCTION TECHNOLOGIES

  • Support in the design and implementation of various technologies in many areas of mechanical engineering (including the manufacture of medical instruments and implants).
  • Experience in metalworking industry (casting, molding, machining, surface treatment, etc.).

CONSTRUCTION AND DEVELOPMENT

  • Support for development projects from start to finish
  • Design and variant construction (mainly 3D construction), preparation of production drawings, design transfer to production
Audits Medical Technology

Internal audits for auditors in medical technology according to ISO 13485 2015, TÜV Süd Akademie, Munich

Contents:

  • Legal and normative framework (ISO 13485, ISO/IEC 17021 and 2007/47/EC)
  • Audit implementation according to DIN EN ISO 19011
  • Importance of internal audits
  • Requirements for internal auditors
  • Overview of the different types of audits, frequency of internal audits
  • Creating audit checklists, planning audits
  • Preparing audits in a practical way: audit questions, audit procedure, audit documentation
  • Audit implementation (including introductory and final meeting)
  • Follow-up and evaluation of audit results
  • Determination and tracking of corrective measures
  • Practical case studies
External Audits For Auditors

Supplier audits in the medical device industry – 2015, TÜV Süd Academy, Munich

Contents:

  • Regulatory requirements for audits of suppliers and vendors
  • Specification of the applicable GHTF documents and derivation for practice
    • Corrective and preventive actions
    • Procedure for conducting supplier audits
    • Planning guidelines for supplier audits
    • Selection of potential suppliers and subcontractors
    • Supplier evaluation and selection
    • Monitoring of suppliers
    • Communication with suppliers
  • Planning, implementation and follow-up of supplier audits
  • Special features of supplier audits
External Audits

External audits – TÜV – 2015, TÜV Süd certificate

Contents:

  • Management systems for medical device manufacturers
  • Risk management and analysis for medical devices according to ISO 14971
  • Corrective and Preventive Actions (CAPA)
  • Process validation in the medical device sector
  • Internal audits for auditors in the medical device industry according to ISO 13485
  • Supplier audits in the medical device industry

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Our specialists

Contact us without obligation

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Quality management systems

Optimization of processes

Internal/external audits

Validations

Risk management

Project management

Development

Supplier management

Regulatory requirements

Additional services

Quality management systems

Optimization of processes

Internal/external audits

Validations

Risk management

Project management

Development

Supplier management

Regulatory requirements

Additional services