These services have been provided to multiple clients.
Guidance / assistance to establish effective / efficient quality management system documentation for medical device companies
Quality manuals that are readable and provide employees an overview of the principles behind the quality management system.
Level 2 procedures addressing what must be done and who is responsible – to help employees see in further detail the principles and strategies to fulfill requirements in their particular areas of responsibility.
Level 3 procedures spelling out step by step how the requirements of Level 2 documentation must be fulfilled, usually supported by flow charts and text closely related to the flowcharts.
Incorporation of principles of product risk management throughout the quality management system.
Harmonization of device requirements with drug requirements where a company manufactures both types of products.
In many cases, this has involved helping to simplify overly complex and unmanageable processes and documentation established by the client in responding to compliance issues without adequate consideration of consequences and available resources. Guidance and assistance in preparation and presentation of training modules
Preparation of training modules in support of quality system documentation.
Creation and presentation of training modules for design control consolidating FDA, ISO 13485 and company requirements.
Guidance and assistance in internal audits
Measuring internal audit effectiveness
Following up after the audit
Preparation of process validation plans for laboratory equipment.
Other quality management system services can be planned and delivered as needed.