Marcia Elena Podboršek, Director, Medical Device Resolve

The world of medical devices holds immense potential to revolutionize healthcare.  Imagine groundbreaking technologies that diagnose diseases earlier, deliver targeted treatments with minimal side effects, and improve patient outcomes. However, the path from promising concept to life-saving technology can be fraught with challenges. Complex regulations, a maze of ever-evolving requirements, and navigating the approval process can easily stall even the most promising innovations. This is where Medical Device Resolve steps in, acting as a trusted guide for companies navigating this intricate landscape.

At the helm of Medical Device Resolve is Marcia Podboršek, a leader with a unique perspective.  Her journey began in the realm of medical device policymaking, where she witnessed the challenges companies faced firsthand.  “I saw the struggle to translate regulations into practical solutions,” she says.  This experience sparked a passion to bridge the gap, leading to the creation of Medical Device Resolve.  The company’s mission is to empower companies to bring their innovations to market while ensuring patient safety remains paramount.

Tailored Solutions for Every Challenge

Medical Device Resolve understands the ‘one-size-fits-all’ approach doesn’t work in the dynamic world of medical devices. They prioritize a client-centric approach, taking the time to understand each company’s specific goals and challenges.  Whether it’s a young entrepreneur with a novel concept for a diagnostic tool or a multinational corporation navigating the European market with a new surgical device, Medical Device Resolve provides personalized solutions that ensure efficient compliance strategies.

Navigating intricate regulations, particularly the EU’s MDR (Medical Devices Regulation) and IVDR (In Vitro Diagnostic Medical Devices Regulation), can be a daunting task. “These regulations are crucial for patient safety,” acknowledges Marcia, “but they shouldn’t stifle innovation.” Medical Device Resolve excels at simplifying the complex. They offer strategic consulting services that guide clients through the entire product lifecycle, from initial design and development to manufacturing and post-market surveillance. This ensures compliance with all relevant regulations while optimizing market access and minimizing delays.  Their ‘Notified Body Finder’ tool is useful for manufacturers to find the notified body that can perform conformity assessment for medical devices and in vitro diagnostic medical devices. It can be used mainly for start-ups and those who due to classification rules are now in the higher class or for those who need a new notified body.

A Shared Mission: Fostering Collaboration and a Brighter Future

Medical Device Resolve believes patient safety and innovation go hand-in-hand.  They actively advocate for clear, predictable, and risk-based regulations by engaging with organizations like MedTech Europe.  This collaborative approach fosters a thriving ecosystem where innovative technologies flourish within the framework of the highest safety standards.

Their commitment extends beyond ensuring compliance. Medical Device Resolve fosters a collaborative spirit within the industry by working with universities and research institutions.  This cross-pollination of ideas between engineers, scientists, and medical professionals accelerates the development of life-saving technologies, ultimately benefiting patients worldwide.  Imagine a world where a university researcher’s groundbreaking discovery in biomaterials connects with an engineer’s expertise in device design, leading to a revolutionary treatment option. This collaborative spirit, fostered by Medical Device Resolve, can make such advancements a reality.

Global Reach: Bridging Borders

While Medical Device Resolve primarily works with companies in Slovenia, their impact transcends borders.  Their in-depth understanding of EU regulations and diverse client experience make them a valuable resource for companies navigating the international landscape. They help companies bridge the gap between regional regulations, ensuring their innovations reach a global audience.  Imagine a life-saving medical device developed in Slovenia reaching patients in critical need across the globe. Medical Device Resolve helps make such global impact a possibility.

Marcia’s background as a former inspector for the Slovenian Competent Authority offers a valuable edge. “Having been on both sides of the process,” she says, “gives me unique insights into the regulatory landscape.” This insider knowledge allows her to anticipate potential challenges and navigate them proactively with clients.  She bridges the communication gap between regulators and manufacturers, streamlining the approval process.

A Beacon of Hope for Medical Innovation

Medical Device Resolve stands as a beacon of hope in the ever-evolving world of medical devices. Under Marcia Podboršek’s leadership, they offer a unique blend of personalized guidance, regulatory expertise, and unwavering dedication to fostering innovation.  By bridging the gap between complex regulations and practical solutions, they pave the way for a future where cutting-edge medical devices reach those who need them most. Their commitment to patient safety and a brighter future in medical technology solidifies Medical Device Resolve’s position as a champion for advancements that revolutionize healthcare.