Training

Qserve offers a comprehensive program of training courses that are tailored to meet your needs and that emphasize the “Practical Approach”.

Training and education is often overlooked by medical device professionals until it is triggered by an upcoming FDA or Notified Body audit. Nevertheless, the requirement for training is an essential element of all Quality Management Systems and should be a key component of your Continuous Improvement Process.

Ranging from half day training courses on specialized subjects to multiple day courses specifically targeted as needed to management or production staff, 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 offers various courses in English and in Dutch, at Qserve offices, at external locations, such as conferences and congresses, and on-site at your organization.

Our trainers all have many years of “real world” experience in many areas of the medical device industry, ensuring your company a high quality training session.

Qserve offers a wide range of courses which encompass every aspect of Quality Management and Regulatory Affairs, including:

• QMS 13485:2003
• Quality System Regulations (QSR) / FDA
• Canadian CMDCAS
• Pre-Clinical & ISO 10993
• Medical Device Directives AIMD, MDD and IVD
• Risk Management Analysis, (EN) ISO 14971
• Auditing (to ISO 13485 / QSR / CMDCAS) internal, supplier and distributor
• IQ, PQ, OQ, shelf life, packaging, sterilization, software and labeling validation
• Vigilance, Recall and Post Market Surveillance (PMS) systems
• Project Management (e.g. Product Development or Design Control)

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