Education & Training Programs
We have extensive experience organizing courses and training. We can train individuals, groups or whole companies in relevant regulatory requirements, in detail or in general as needed.
We can deliver training at your premises, providing a cost-effective way of training a largergroup.We have descriptions of several courses where we have successfully trained customers, and we are happy to adapt any course to your company’s need.
A one-day course that gives a detailed introduction to the standard and gives the participants a solid knowledge of the standard purpose and content.
A one-day course describing the development phases and the requirements for key documents for each development phase, from Design Planning to Design Transfer.
CE Marking & FDA Approval
A one-day course focusing on then European approval processand the content of the Medical Device Regulation, but also introducing the FDA approval process.
Risk Assessment –ISO 14971:2019
A one-day course that makes the participants capable of performing FMECA risk analysis according to ISO 14971:2019for devices and production equipment. The course incl. several practical FMECA exercises.
Human Factor Engineering -IEC62366
A one-day course that makes the participants capable of planning and performing as mall HFE study according to IEC 62366 standard requirements.
GMP for Medical Devices
A one-day course that gives the participants a solid knowledge of the different GMP requirements related to the development and manufacturing of a medical device.
A one-day introduction course for equipment validation. The course introduces the basic disciplines within Installation Qualification(IQ), Operation Qualification(OQ)and Performance Qualification(PQ).
Basic & Advanced Statistical Tools
P4E QA provides several hands-on courses in statistical methodology ranging from basic introductions, to advanced techniques for data processing and modeling.
Medical Device Documentation
A one-day course where all key documents required for each phase of a development project is explained.
IVD Regulatory Requirements
A one-day course that gives the participants a detailed knowledge of the authority requirements and expectations for the technical documentation.
Good Documentation & Test Practice
A half-day course going through all the documentation rules and explaining why these rules are important to comply with in relation to the safety of the user.
A one-day course that gives the participants a basic auditor training incl. practical exercise in preparation of audit plan, audit program and audit report.