healthcare projects consulting & management Stein
A Trusted Partner for Medical Device Registration and Compliance

It is imperative to understand the regulatory perspective that plays a vital role in the industry in order to implement medical equipment manufacturing. However, as early as 2000, there was a lack of understanding of regulations and quality management systems by medical device companies and hospitals.

To that end, Prof. Dr. Frank Stein, CEO of healthcare projects consulting & management Stein, established the company to support medical device manufacturers and hospitals and ensure that patients and healthcare institutions have access to quality medical equipment. He helped them focus on research and development activities by teaching regulations and supporting the implementation of quality management systems.

It has promoted transparency and regulatory alignment between participating authorities and minimized the need for multiple audits, thus saving the time and resources of medical device manufacturers.

In addition, Prof. Stein believes that the changes from the prior legislation to the EU medical device regulation (EU MDR) increased the workload by 50 – 75% percent between 2017 and 2021, with many companies seeking consultation. Businesses approached healthcare projects consulting & management Stein seeking assistance in conformity assessment or documentation of research and development of their medical devices. With its team of one scientist and two engineers, Prof. Stein provides 360-degree consulting to meet its customers’ requirements.

To develop its clientele into independent customers, healthcare projects consulting & management Stein deals with the conformity of medical devices and furnishes relevant regulatory requirements for Switzerland, EU, Australia, Brazil, Canada, Japan, and the United States. It provides welldeveloped processes and a management system compliant with ISO 13485 requirements and regulations.

“As a medical engineer and professor, I have specialized in medical device quality management and regulatory compliance since 2000. 360-degree consulting ensures our customers are supported until they are self-sufficient,” says Prof. Dr. Frank Stein, CEO of healthcare projects consulting and management Stein.

In engaging with clients, Stein’s core team learns three critical aspects: what is the product? What is the structure?

And what are the processes? Furthermore, it interacts with CEOs of businesses to discover how they train their staff to become independent consultants and understand their dayto- day operations and pain points

That’s not all.

healthcare project management and consultancy Stein examines their website, quality management system, documentation, and standard operating procedures (SOP). Likewise, it acknowledges the employees of organizations on various levels, from the manufacturing worker to the CEO, perusing the documentation and technical manuals. By identifying gaps in the documents’ compliance and discrepancies between the real world and the company’s planning, it explores ways to bridge the gaps and move the organization closer to being compliant in the real world.

A testament to healthcare projects consulting & management Stein is the case of a company headquartered in the US, the European management located in France, and the manufacturing and sales activities located in Germany. When the company’s CEO resigned and a new CEO was appointed, he contacted healthcare projects consulting & management Stein.

As a medical engineer and professor, I have specialized in medical device quality management and regulatory compliance since 2000. 360-degree consulting ensures our customers are supported until they are self-sufficient

During his visit, Prof. Stein spoke with the CEO and the department heads. There was a framework in place, but it was significantly dissimilar from the real world. The former CEO did not spend enough time planning, without any sources established 20 years ago. Similarly, the new European medical device regulation’s technical documentation and lab test criteria were not covered. To that end, healthcare projects consulting & management Stein completed a gap analysis, produced a report, and established a project plan in two months.

It planned to alter the technical documentation from the previous legislation to the new legislation and change processes to make them more adequate.

healthcare projects consultancy & management Stein suggested increasing the hiring and training of new employees. The company was satisfied with how quickly it progressed from having extremely low compliance to achieving a high degree of compliance. The customer made additional use of their reviews and compliance for marketing.

healthcare projects consulting & management Stein is the cornerstone of many similar success stories today, showcasing their corporate strategy, corporate orientation, and commercial success. Treading ahead, it will continue to support its clientele with conformity assessment or documentation of the research and development of its medical devices.