QM Consulting
Setting up QM systems
Benefit from our many years of experience in the implementation of efficient and requirement-compliant QM systems:
- Development of a customized QM system according to
- EN ISO 13485
- 21 CFR 820
- European medical device regulations (MDD and MDR)
- Further requirements of international regulations, e.g. EN ISO 9001
- Implementation of all processes required for development, production and marketing
- Training of the new QM system, adapted to the different user groups
- Accompanying support for your employees during the introduction phase
- Support during internal audits and management reviews
- Support during certification audits
- Long-term support in establishing and optimizing your QM system
Introduction of a QM system for dealers and for suppliers
We support you in qualifying as a dealer and supplier and equip you with efficient and requirement-compliant QM systems:
- For manufacturers: Support in the selection, qualification and monitoring of your dealers and suppliers at home and abroad.
- For distributors: Establishment of a MDR-compliant QM system (new requirement!), which can also include non-European requirements.
- For suppliers: Advice on the introduction of a new QM system or the extension of an existing one.
Implementation of internal or supplier audits
Our auditors bring external know-how to your company:
- Joint definition of the audit scope, the company units to be evaluated and preparation of the audit schedule
- Review and analysis of the documents/records provided on processes and products
- Conducting audits to evaluate the effectiveness of the QM system and/or technical documentation at the customer’s site
- Conducting audits at supplier sites to assess compliance with process specifications and specified product quality and documentation
- Evaluation of the performed root cause analyses, corrections and corrective actions
- Effectiveness evaluation for corrective and preventive actions
Preparation and support for audits and inspections
Our consultants accompany you through the audits and inspections:
- Joint review of the audit schedule with the customer, formulation of change requests if necessary.
- Review and analysis of the documents/records provided on processes and products
- Conducting a pre-audit/mock audit and preparing a gap analysis
- Support in the elimination of existing deviations
- Support/coaching during external audit/inspection
- Joint review of the audit report with the customer, formulation of change requests if necessary
- Support in the root cause analyses, corrections and corrective actions to be carried out
- Support in the effectiveness evaluation for corrective and preventive actions
Implementation of MDSAP mock audits
Our consultants will prepare you for MDSAP audits in a targeted manner:
- Conducting mock audits according to the same process-based MDSAP audit model used by the approved auditing organizations
- Identifying gaps to MDSAP requirements and proposing specific solutions to close the gaps
- Coaching on the application of risk-based thinking
- Development and review of MDSAP audit checklists
- Alignment of your internal audits with the MDSAP process
- Assessment of the proper registration of your products in participating countries and fulfillment of MDSAP reporting requirements
Expert opinions on and evaluation of products and processes
Our consultants evaluate the quality and completeness of the technical documentation of products and processes with a neutral external view:
Visit to get to know the company, its employees, its products and processes
Reviewing/analyzing the documentation provided
Conducting interviews to assess the key players
Review of processes for conformance to requirements
Review of documents/records to evaluate
the concepts
the maturity of components and products
of the approvability
Review/analysis of subsequently supplied documents
Elaboration of the expert opinion/evaluation
Presentation of the expert opinion/evaluation to the client
Support for further development and optimization of products and processes
Training on process, quality and regulatory topics
Qualified employees are the prerequisite for successful work. We support you with in-house training on a wide range of issues:
- QM systems for medical device manufacturers, distributors and suppliers
- Risk management for medical devices according to EN ISO 14971
- Development of active medical devices in conformity with EN 60601-1
- Software development according to EN 62304 and EN 60601-1, chap. 14
- Usability according to EN 60601-1-6 and EN 62366-1
- FDA-compliant product and software development (design control)
- Regulatory affairs training for worldwide approval
- Post Market Surveillance, Vigilance and Post Market Clinical Follow-up
- Safety officer according to § 30, medical device advisor according to § 31 MPG
- Responsible person for regulatory compliance according to Article 15 MDR
Training as internal and supplier auditor
Training to perform clinical evaluations according to MEDDEV 2.7/1 Revision 4