Qserve Group offers medical device manufacturers training at all regulatory, quality, and clinical levels. As a global medical device consultancy organization with offices in Europe, the United States and China, Qserve's staff offers years of international experience, with both broad and specific expertise for a wide range of medical devices and IVD's. This time, we held an interview with Peter Reijntjes, Qserve’s Head of Training.
1. What developments do you see in the global medical device industry?
Of course, the upcoming changes in the European Medical Device Regulations (EU MDR and EU IVDR) set into motion in May 2017 dominate the regulatory landscape. We should not overlook that in other parts of the world, regulatory requirements and guidances are constantly being updated. For instance, in the USA and Canada the implementation of the MDSAP program. In addition, the greatly increased use of software in medical devices themselves, however, also in the production process and supply chain, software validation and process validation play a bigger role than ever before.
Moreover, stricter use and interpretation of these Regulations, guidance documentation and associated Standards ask for an increasing need to understand the in-depth contents of these requirements and to be able to identify the impact thereof on the own organization and processes.
And last but not least, Regulators and Notified Bodies require more and more the manufacturers provide objective evidence of competence of their staff. Evidence of in-depth knowledge and skills of appropriate staff is prerequisite for regulatory compliance, apart from process conformance and product compliance.
2. In which specific area is a need for training?
The EU MDR and IVDR of course pose a focus on the new requirements of e.g. Clinical Trials and Clinical Evaluation, Post Market Surveillance including Post Market Clinical Follow up and Technical Documentation; but also the added requirements for Economic Operators in the Supply chain. In addition, the first steps to world-wide harmonization of auditing, the MDSAP program, askes from manufacturers to gain insight in the content and impact of these requirements, to be prepared for such an audit.
‘Old-fashioned’ subjects as Internal auditing and CAPA management remain important to implement a pragmatic approach to comply. The CAPA process is for many years the number 1 deficiency in FDA inspections!
We do that by offering in-house trainings, open training courses, and webinars.
In-house training offer the advantage of fine tuning and adapting a training course exactly on the required learnings of the organization. Using examples and contributions from the own organization turns a training into a workshop-like approach with direct and usable results. Actions and improvements can directly be identified and set into motion.
Open training courses offer advantages as the ability to meet and network with peers from other organizations; you share knowledge with people from other companies; small groups which means almost individual coaching; you gain valuable insights from different industry sectors, and it is an approachable way for companies (also start-up companies) to send 1 or 2 employees for training.
Webinars offer the advantage to follow the course via the Internet and does not require extensive travel and sometimes can even be watched at your own chosen time and convenience.
3. How are the training courses put together (theoretical vs. practical)? And how do participants rate our training?
The ‘practical approach’ is leading for Qserve. It is natural for us to unravel a subject into logical and understandable chunks. A clear understanding of the theoretical contents, ‘what does it mean’, is alternated with a practical application, ‘how do I implement it’. We therefor include practical cases and exercises in our trainings to ‘learn by doing’. By varying learning methods, we strive to an appealing training course with something for everyone. Even ‘homework’ can be used to effectively and efficiently perform a training and we even do not hesitate to use role-plays in training situations!
We create a safe learning environment where participants can afford to make ‘mistakes’, characterized by the classroom situation. One learns from mistakes as much as from successes, don’t we?! A quiz or even an examination can be used to finalize a training and determine whether the learning objectives have been achieved.
In-house trainings are of course much more focused on the individual needs and the specific situation of each company. Adaption and fine tuning can be realized to a high extent.
From the feedback we get, this training approach is highly appreciated and strengthens our conviction that this is the right way to go.
4. Why is it crucial to get trained in general? And more importantly, why should people follow Qserve’s training?
Training is crucial for several reasons: first, well-trained staff are more able staff. A greater understanding of the content and importance of their role contributes directly to the organization. It is important that people not only know what to do, but also why to do it like this. Secondly, the constantly changing environment of regulatory requirements, the continuous update of associated standards and rising expectations of Regulators and Notified Bodies. The baseline of meeting regulatory requirements is constantly shifting, and a responsible organization must move along and preferably upfront.
Qserve’s trainer group is up-and-running with regulatory requirements and associated standards and guidelines. They have many years of experience as former employees from Notified Bodies, Authorities and multinational companies. Most importantly, our trainers are also consultant, continuously gaining expertise in their field of implementing Medical Device Regulations in a pragmatic and practical approach.
Your compliance is our success!