Qserve offers medical device manufacturers training at all regulatory, quality, and clinical levels. As a global medical device consultancy 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. We highlighted several questions for Stefan Menzl, Executive Director of Qserve Group Deutschland GmbH.
Interview part 2:
(Interview part 1)
In which specific area is the need for training? In which subjects?
There is an increasing need to understand the content and impact of the new requirements like MDSAP and MDR in Europe. Based on a solid understanding of what is expected from the medical device manufacturers from the authorities, companies can define strategies to meet these requirements. Qserve can help with educating about the requirements and in the next step with developing and implementing a pragmatic approach to comply.
We do that by offering in-house training, open training courses, and webinars.
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Open training courses can sometimes offer even more than an in-house training program can. The advantages are: meet and network with peers from other organizations; you share knowledge with people from other companies; small groups which means time for 1-2-1 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.
How would you describe a Qserve training?
Qserve stands for the ‘practical approach’. This means we not only help delegates who participate in our training understand the theoretical content of regulations and other regulatory documents, however, we
give practical examples and offer practice-oriented solutions. In-house training are
anyway very much focused on the individual needs and the specific situation of each company.
Why is it crucial to get trained in general? And more importantly, why should you follow Qserve’s training?
Training and development are critical for any professional and any professional organization. It helps you improve your performance and helps your organization meet its business goals. Building new skills makes an individual more efficient at a job or capable of handling different responsibilities and challenges.
Training presents a prime opportunity to expand the knowledge base of all employees. Employees who received the necessary training are more able to perform in their job. The training will give the employee a greater understanding of their responsibilities within their role and, in turn, build their confidence. This confidence will enhance their overall performance, and this can only benefit the company. The investment in training that a company makes shows employees that they are valued. The training creates a supportive workplace. Productivity usually increases when a company implements training courses. Increased efficiency in processes will ensure project success which in turn will improve the company turnover and potential market share.
In a heavily regulated environment like the medical device industry training to stay on top of current and upcoming requirements, training becomes the differentiator between successful companies and those that will no longer be successful.
Qserve trainers are on top of the latest and upcoming regulations. They have years of experience as former employees of Authorities, Notified Bodies or multinational medical device companies.
This means great value for money if you attend our trainings. We offer them at different locations in Europe, the US and China. In-house training is also an option.
What makes our trainers unique in the market?
We are proud of our team of scientific educated and experienced staff members! Together, we are capable of managing all kind of regulatory compliance projects in the medical device industry. Working with a global team of experts, Qserve manages a diverse array of projects in the medical device industry. Together, we bring your medical device to the global market, complying with international regulations and assuring product quality and safety. This and the professional background of team members, who have previously worked at Authorities, at Notified Bodies or at multinational companies in industry, allows us to offer you ‘the practical approach’ in training and consulting.
If you opt for in-house training, depending on your needs and requests, and the medical devices involved, we will create a dedicated training session for you.