Company Presentation

Company presentation
Besser Visser AB is a consulting company founded by Christian Kaestner. The company is active within the medical device industry, primarily focusing on all kinds of software. 
The company delivers services worldwide.  
With only a single consultant, the company obviously have capacity limitations! But being a small company has its advantages in being flexible and delivering fast and efficient support to clients. 
In addition to providing consulting services, the company offers online training in collaboration with Medical Device HQ.

This is Christian

Christian started his work life as an entrepreneur and co-founded several companies. One of the companies, Innovation Team, was an R&D consultant company focusing on supporting clients in their innovation process and development of new products.
In the early 90ths, Christian started his career as a software developer. After almost 10 years of working in different industries, the focus narrowed, and he has now enjoyed working with medical devices for more than two decades.

Over the years, Christian have had different roles such as; software developer, chief technical officer, project manager, R&D QA and much more.

Since 2013, Christian has been actively participating in the project team authoring IEC 62304 and IEC 82304-1.

Christian is driven by being lazy! “I aim to develop the safest possible device while spending as few resources (including my time) as possible.”

What we offer

Review of technical documentation
If you are looking for a second opinion on your technical documentation, we can assist you in reviewing and providing improvement suggestions. Typically, such review is based on ISO 14971, IEC 62304, and IEC 82304-1. There are also many applicable guidance documents for many regions, but the standards usually provide a good starting point.
Training
We mainly offer training in collaboration with Medical Device HQ. If you are looking for company-specific training on IEC 62304, we suggest asking for an in-house version of the blended course on IEC 62304.
Audits
We can provide various versions of audits, such as: General internal audits per ISO 13485, mock-up external audits per ISO 13845, focused software audits per IEC 62304 and when applicable IEC 82304-1.
Quality management strategies
Struggling with cumbersome quality management systems eating up the time available for innovations and creative work is counterproductive. We are happy to help you review your existing procedures and provide suggestions on improving your way of working while still staying compliant.

Contact

You are welcome to contact us by connecting with Christian on Linkedin, where he regularly shares thoughts and news about medical device software. 
If you want a more in–depth discussion, we suggest booking a “Meet and greet” by using the booking button to the right. Usually, a quick chat in a webmeeting is faster than writing lengthy e-mails! 
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