Training

Supplementary training and education is often overlooked by medical device professionals until it is triggered by an upcoming FDA or Notified Body and/or ISO 13485:2003 certification audit. The requirement for training is, nevertheless, an essential element of all Quality Management Systems, and should not be confined to only those occasions. Several bodies in the US and EU offer training on standards such as ISO 13485 and ISO 14971, however, Qserve is able to offer training which is tailored to meet your needs. This can vary from a half-day training course on specialist subjects to multiple-day courses, specifically targeted at management or production staff, as required. These courses also offer an opportunity to meet fellow professionals and to exchange valuable information. They are conducted in small groups with a specified maximum number of participants.

Qserve consultancy, in co-operation with Qserve America, delivers courses and training in English and in Dutch, at Qserve offices, external locations and on-site at your own organization both in the EU and the US. These can be concluded, if required, with an examination and/or certificate.

Our expert trainers all have many years of “real” experience in their own particular areas of the Medical Device Industry, ensuring your company a high quality training session. Qserve offers a wide range of training courses which encompass every aspect of Quality Management and Regulatory Affairs and emphasize the “Practical Approach” , including:

• CE Marking of medical devices conform the European Medical Device Directive(s)
• "Introduction to the Medical Device Directive - a better understanding"
• "Medical Device Directive compliance"
• Update European legislation for medical devices
• Device classification
• Conformity route assessment
• Content Technical File
• Content and understanding STED Filing
• Implementation of Complaint, Recall, and Vigilance systems
• Post Market Surveillance (PMS) systems
• Risk management according to EN ISO 14971
• Pre-clinical Testing, Clinical (study) evaluation, Shelf life, Labeling, Packaging and Sterilization
• Biocompatibility and safety issues
• Clean room validations and monitoring
• IEC 60601-1-8
• ISO 13485, Medical Devices - Quality Management Systems – Particular requirements for regulatory purposes
• Training covering auditing processes such as:

“Internal & supplier auditing” in the medical device industry, including: internal quality auditing, supplier auditing and distributor auditing

• FDA/QSR, Quality Systems Regulations, requirements
• CMDCAS and CAN/CSA requirements
• FDA regulatory requirements such as 510k filing
• CMDR, Canadian Medical Device Regulations
• Requirements for Australia and New Zealand
• Project Management in the medical industry
• Design and development processes

For more information please click on the tabs in pull-down menu above.

If you didn’t find exactly what you were looking for in this list, please contact us so that we can discuss your particular training requirements.

Please note! For the Benelux the Quality Management System courses are provided in conjunction with our partner NEN , the Dutch Standardization Institute, and are normally delivered in Dutch. If required, they can be given in English.

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