New requirements for medical devices affordable for start-ups

Helen Lepa joined Tehnopol’s team of health tech mentors with a primary focus on consultancy services for creating and improving quality management systems. Helen also advises companies on requirements relating to the manufacturing of medical devices.

Helen’s interest in quality management systems began with her first job at the Veterinary and Food Laboratory and has grown with each subsequent position that has been directly or indirectly related to quality management systems or requirements for medical devices.

“Building a quality management system is like solving a good crossword puzzle where all the rows and columns have to come together to meet all the requirements and make sure the processes are smooth, logical and adequate. It takes a lot of thought and it’s a lot of fun,” says Helen.

She also likes the idea that medical devices and tests should be as accurate as possible within their context and have minimal measurement errors. She has really enjoyed being involved in processes where she has had the opportunity to contribute to the development or validation procedures.

New regulations lead to certain changes

According to Helen, an important topic at the moment is the new EU regulations on medical devices and in-vitro diagnostic medical devices (devices for the examination of tissue samples or the analysis of data obtained from the examination of tissue samples). “The new regulations are rooted in scientific and technological advancements and there is therefore now more focus on things like software-based medical devices and genetic studies compared with the previous directive from 1993 when such devices were less common,” says Helen.

The main change introduced by the new regulations is that for many medical devices, a notified body must be involved. This means that an external auditor will be assessing both the technical documentation related to the product, including the adequacy of clinical safety and evidence, and whether the manufacturing company’s quality management system is compliant with the applicable requirements.

According to Helen, it is important to remember the positive side of stricter requirements and external control – the regulation aims to ensure fair access to the EU market for manufacturers. “The rules are strict and apply to everyone. Even start-ups are able to comply with these requirements and successfully pass these audits. Nothing about this process is downright impossible or available only for large manufacturers,” assures Helen.

Are Estonian manufacturers conscious manufacturers?

Speaking about Estonian manufacturers and their level of awareness of the current requirements, Helen Lepa said that the issue needs to be divided into two, with a focus on the introduction of quality management systems and ensuring that the clinical evidence is sufficient.

If the manufacturer has previous experience with implementing quality management systems, external audits, etc., then it is relatively easy to introduce new procedures or upgrade existing ones. “However, if you are starting from scratch, it is quite a big undertaking and requires a certain change in mindset, describing the spontaneous activities that have been done so far and then sticking to the procedures that have been agreed on, giving meaning to a risk-based approach and enforcing it in real life,” says Helen, adding “I believe it is possible to build a quality management system within a year if you get a good start.”

Awareness of the specific requirements applicable to medical devices depends on the maturity of the manufacturer’s organisation. The requirements applicable to a specific medical device may vary, for example in terms of which ISO standards to comply with and which to ignore. If a company has implemented a quality management system that complies with an ISO standard, it will generally have better awareness of other applicable ISO standards.

“The second issue is related to the clinical evidence and the conducting of studies to this end. Since it is essential to carry out such studies at a very high level, including with proper documentation, to ensure the safety and functionality of the device, it seems to me that it is very important to increase knowledge in this field in Estonia,” says Helen.

Plans as a mentor

As a new mentor, Helen is keen to work with all companies in the Connected Health cluster who have a need for or interest in building quality management systems or who are currently tackling the matter but have run into some issues or obstacles.

“In addition, it would be great to organise joint workshops with cluster members to discuss more or less all the stages of developing and manufacturing medical devices, involving external experts if necessary and going through the relevant procedures and verification documentation,” says Helen.

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