Cyber
Biomedical
Engineering
From making strategic decisions to developing your capabilities, I’m here to help. Using my expertise and deep understanding of the biomedical industry, you’ll receive real solutions and experience true results.
I know Mikolaj from his first day at UL and observed him at different stages of his career. Starting with the engineering knowledge and technical decisions (medical is my technical background) through customer handling, cooperation with coworkers, all the way to being Engineering leader and manager - with full confidence I can recommend Mikolaj. His enthusiasm, openness, and creativity supported by solid technical and managerial skills are great foundations for future success.
Bogdan Maliszewski, Managing Director, UL
I have known Mikolaj in a variety of capacities for almost 13 years. First, as a peer, and then also as my direct supervisor. His positive, enthusiastic and customer oriented attitude combined with solid technical skills, out-of-the-box thinking manner and a truly people-oriented leadership style, made him a unique teammate and a real asset for the company. Top grade in both professional and personal levels. As a team member or a leader, Mikolaj earns my highest recommendation.
Jakub Sobolewski, Staff Engineer and Lead Reviewer, UL
Mikolaj is an experienced and highly professional engineer in 601 series of standards, Mikolaj is very much focused to meet customer and business needs. Mikolaj is able to deliver projects and tasks by understanding then delivering with urgencies and focus required.
Paul Daysh, Operations Manager, UL
I've known Mikolaj for almost 12 years. First as a colleague working in the same office and then as engineering leader of a team I've had the privilege to work with. As the leader of the group he has always been there to help and support. Very customer oriented and full of ideas, taking initiatives even if they are outside of his daily activities / responsibilities. Very reliable manager and colleague. A leader every company should strive for!
Meg Chocholska, Regulatory Specialist, UL
I had the pleasure to meet you and mentor you, through the Green Belt curriculum and certification, since 2016.
During your GB project, you have demonstrated exceptional leadership, perseverance and commitment! Your project on the Net Promoter Score response rate and score had a tremendous impact not only on your Business Unit but all UL, as many other BUs applied the improvement actions globally. Since your certification and always leading by example, we have continued our collaboration on the different process improvement initiatives that you have identified. Mikolaj, you are a recognized and trusted leader by the teams and peers, you have strong technical, project management and continuous improvement skills and I would definitively recommend you.
Marilena Tsetsi, Master Black Belt, UL
We have worked together for many years now and I have and observed your performance at different stages of your career. I have observed your strong technical skills in medical and the positive manner in which you have trained and qualified other staff including those in regions outside where you reside. You also have a keen focus on customer satisfaction/loyalty and a drive for process improvement through a successful Lean/Six Sigma Green Belt project that helped to improve customer net promoter score in Europe. With full confidence I can recommend you.
Deborah Jennings-Conner, Director, UL
Having worked closely with Mikolaj for a number of years, I can safely say that he would be a strong asset within any TIC business. His strong technical competency is matched by an enthusiastic customer focus, which was fostered within his engineering team and provided the perfect recipe for both major health tech companies and new businesses alike. On several occasions, Mikolaj volunteered to provide bespoke 60601-1 training to our clients which was considered to be best in class and further instilled trust in the services of UL.
Kurt Dennis, Senior Account Executive, UL
Mikolaj Krukowski
cyberbiomedical@gmail.com
My Articles
Safety, Performance, Risk Management, Quality, Reliability, Usability, Medical Software
IEC60601-1 ISO14971 ISO13485 IEC62366 IEC62304
Usable or Useless – which will your next product be?
To achieve market success with your next product you will need to do some more than simply design a safe product. Here comes usability, an attribute just as important as safety. In fact, usability is an attribute that will not only improve your product safety, via safer use and lower user errors, but will make product use more efficient by making your customers more effective in their jobs and everyday tasks; they will be much more satisfied and will have more fun performing their routine tasks when using your product. Customers quickly develop certain preferences based on their perception of the products they buy.
Leaders in Labyrinth
It’s simple. In a fog of complex strategies, imperatives, commercial goals, visions, missions and processes, people lose their focus and may not see what is most important. This applies to everyone in the company, leaders and managers too. Gaining and retaining customer trust is the single most important task of every manager and leader, and when accomplished it will set up the business for future prosperity and profit. The best way to do this is to maximize talent retention no matter what. Throughout all your actions and behaviors make sure that talented people will always want to work for the company. To achieve this, always listen to them carefully, with trust and confidence.
Monster or Manual – what is IEC60601-1 ?
The history of medical safety standards over the last three decades is proof that evolution exists, at least within medical safety science. In the beginning, requirements and safe limits were different, defined in different standards, published on different continents, and had to go through semi-harmonized processes. But over time they have developed into a well-defined, holistic and globally harmonized approach to medical product safety and effectiveness, as defined in the current edition of the 60601-1 series of standards. It’s been a long journey, but one of great importance and advantage to medical product manufacturers: we have finally reached a time when safety requirements for medical products are harmonized globally, which significantly streamlines processes and efforts towards safe and effective medical products entering global markets.
Radiation Safety in Radiotherapy
Radiation Protection around Linear Electron Accelerators. How major radiotherapy incidents led to safety standards development and enforcement. The first linacs were deployed in healthcare in the 1960s, much earlier than the first MRI systems (1983) and CT scanners (1971). So, the technology should be well developed now, what could possibly go wrong? Well, the entire history of radiotherapy equipment is actually a story of continuous improvements of technological and system safety.
My 20 years’ experience in medical engineering
While working within biomedical engineering for the last 20 years, and medical electrical product safety evaluations over the past 12 years, I have noticed that even the largest and most experienced companies can struggle. Market access is a sophisticated process, involving several major aspects of engineering
