Medical Device Resolve
Mastering the Medical Device Regulatory Game

The story of Marcia Elena Podboršek, the driving force behind Medical Device Resolve, epitomises the power of the ‘one-person band’ philosophy in navigating the intricate maze of medical device regulatory compliance. Her bespoke approach, a perfect fusion of personalised attention and hands-on service, not only guarantees regulatory compliance but catapults patient safety to uncharted heights through a trifecta of agility, precision and tailor-made solutions that are as unique as the challenges they address.

Her extensive involvement with Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) since their launch by the European Commission in 2017 equips her with a profound understanding of the regulatory terrain. Prior to founding the company, she also led the medical device sector at the Slovenian Competent Authority, which sharpened her industry knowledge with like-minded professionals.

“I thrive on tackling challenges that demand a broader knowledge base and innovative thinking,” Marcia asserts—her expertise in medical device compliance resonating with clarity and passion.

Adaptability is another hallmark of her leadership, keeping her firm at the forefront of the latest developments in the medical device sector and allowing her clients to smoothly integrate these advancements into their operational frameworks. Her innovative streak is particularly evident in the proprietary software she developed, which streamlines the process of searching the correct notified bodies for conformity assessment procedures in Europe. Clients simply enter a product code and instantly receive detailed information on the appropriate notified bodies, avoiding the need for time-consuming manual searches through the NANDO database and boosting operational efficiency. Although some notified bodies have not fully complied with the requirement to provide price lists, Marcia has managed to secure essential data, enhancing the software’s value.

She is, however, mindful that such innovation is just barely scratching the surface. “There remains a substantial amount of work to be done, and fully understanding the regulations’ underlying intentions is crucial,” she notes. “Through Medical Device Resolve, my aim is to guide companies through these regulatory intricacies and help them implement the necessary changes to meet the European Commission’s stringent standards.”

Adaptive Strategies for Every Business Size

Understanding and adapting to the distinct cultural and operational needs of each client is central to Marcia’s approach, as she knows no two companies are the same.

Her strategies are designed not just to ensure compliance but to enhance each stage of a product’s lifecycle— from development to post-market activities—boosting overall business efficiency.

The methodology is perfected to match diverse corporate environments. While large multinational companies often operate within rigid compliance frameworks, small to medium-sized enterprises—which make up 92 percent of European businesses—tend to prefer and benefit from more flexible approaches. Recognising these differences, Marcia tailors the implementation process to suit each company’s needs, taking into account factors such as product classification and workforce size, allowing them to navigate the regulatory waters more effectively.

Most importantly, by helping clients understand the ‘why’ behind new regulations and demonstrating how these rules lead to safer products, Marcia focuses on the long-term benefits for their businesses. She emphasises that compliance is not just a box-ticking exercise but a means to drive continuous improvement and innovation. These benefits include improved complaint tracking, better identification of manufacturing issues and guiding companies towards a future where compliance and success go hand in hand.

“It’s all about looking at the whole forest, not just individual trees,” Marcia remarks.

Whether working with small businesses or multinational conglomerates, Marcia’s guiding principle remains consistent—prioritise what’s important and avoid the pitfalls of overextending. This focus on doing a few things excellently rather than many things adequately is essential to the ongoing learning and improvement process in regulatory compliance.

Simplifying Success with the KISS Principle

What sets Medical Device Resolve apart in its collaborations is Marcia’s adherence to the KISS principle—keep it simple for success. It becomes the backbone of her client engagement strategy, making every interaction straightforward and profoundly effective.

Consider a medical device manufacturer new to the quality management system (QMS), especially one unfamiliar with ISO standards. Marcia applies the KISS philosophy to demystify the process, enabling quicker and more effective adherence to regulations. What may work for industry giants might not be appropriate for smaller firms. She begins by addressing all immediate regulatory obligations tailored to the client’s situation before building on that foundation.

There again, starting with an overly complicated system can confuse and overwhelm. Instead, she focuses on educating clients about the purpose of the QMS and its crucial role in their operations, highlighting how the quality of the final product directly impacts patient safety.

The ultimate goal? To seamlessly integrate the QMS into the company’s culture, simplifying the compliance process and embedding a lasting ethos of excellence and care within the organisation.

Streamlining European Market Entry for International Medical Device Manufacturers

For non-EU manufacturers, appointing an authorised representative and an importer within Europe is mandatory. However, as outlined by Medical Device Coordination Group (MDCG) guidelines, these roles must be held by separate legal entities—a stipulation often overlooked by manufacturers seeking to streamline their operations with multiple importers.

Through Medical Device Resolve, my aim is to guide companies through these regulatory intricacies and help them implement the necessary changes to meet the European Commission’s stringent standards.

In response, Marcia advises her clients on the strategic advantages of appointing a single importer based in a central warehouse, which distributes products through various distributors. This approach streamlines logistics and enables clients to establish their presence in Europe efficiently as distributors rather than importers, significantly reducing operational complexities.
Marcia also navigates the intricate business relationships between countries like Switzerland and the UK post-Brexit. She ensures compliance with the UK Conformity Assessment (UKCA) mark and Swissmedic regulations. Her commitment extends to her home country of Slovenia, where she collaborates with the Slovenian MedTech Chamber and Medtech Europe to overcome the challenges of introducing innovations to the European market amidst stringent regulations.

From Compliance on Paper to Real-World Implementation

In her work with large medical device distributors in Slovenia, Marcia has often faced challenges when documentation—such as certificates and declarations of conformity—does not align with actual regulations. This problem was particularly evident in a well-known, large company, highlighting the complexity of managing compliance across various medical devices and multiple departments. Marcia noted each department focused intensely on their area of expertise, which often led to a fragmented view of the company's overall compliance landscape. This narrow focus caused the client to lose sight of the cohesive 'red line' connecting all compliance aspects.

To rectify this issue, Marcia advocated for a strategic shift towards incremental changes. She suggested starting with small, impactful adjustments, such as revising a single sentence in a critical document, to catalyse wider improvements. Systematically reviewing and revising the company’s technical files, instructions for use and other relevant materials, she transformed compliance from a static requirement into a dynamic, ongoing process.

The company, as a result, could then set clear, achievable goals and maintain a steady focus on progressing towards those targets.

Charting the Future of Compliance World with Education

Right now, Marcia’s Medical Device Resolve is taking a proactive approach to shaping the future of medical device compliance by participating in an educational program in Slovenia. The objective is to enlighten medical staff in hospitals, pharmacists and even patients about the critical vigilance process. The program delves into essential topics such as the criteria for reporting incidents to competent authorities, the definition of a serious incident and other vital regulatory details, equipping its participants with the regulatory armour they need to brave the challenges ahead.

Marcia finds immense satisfaction in contributing to these learning modules, reflecting her zeal for disseminating her knowledge and expertise to help professionals enhance their understanding of patient safety and drive the medical device industry forward.

“I believe in the power of authenticity and delivering information that I feel is most pertinent at any given moment. By staying true to myself and my expertise, I can provide invaluable insights and guidance to those eager to understand the stringent regulatory shadowing every move in the medical device sector,” Marcia shares.

As the medical device industry advances, Marcia upholds the promise embedded in her firm’s name—adeptly Resolving compliance challenges to ensure life-saving Medical Devices reach those in need.