MDRC
The Medical Device Compliance Expert

Patient safety continues to shape the life science compliance landscape, and businesses need to address the evolving regulatory requirements spanning various geographies, business activities, and functions. They face compliance challenges as they seek to push boundaries of innovation, developing and launching products in new markets. Particularly, medical device companies from Central Europe bringing their product to the highly regulated European market often find it tough to navigate the complex regulations put forth by the EU.

They need renowned local experts to guide them through the regulatory maze, ensuring easier market entry for long-term success and improved clinical outcomes. Established by compliance veterans, MDRC checks all the boxes to become a trusted partner for medical device companies seeking to expand their footprint to the European market.

The young, ambitious Slovakian medical device regulatory specialist is an emerging player in the life sciences regulatory space that helps medical device companies comply with medical device regulation (MDR) and in vitro diagnostic medical devices regulations (IVDR). A team of PhD-level specialists and seasoned auditors brings deep industry knowledge to assist clients in identifying and mitigating potential risks associated with regulatory compliance and product quality. This deep-rooted expertise enables MDRC to offer a comprehensive service portfolio, encompassing regulatory and quality assessments, MDR 2017/745, 21 CFR 820 and ISO 13485:2016 quality auditing, regulatory submissions and registrations.

“Our strength lies in specialized consulting services tailored to the needs of small and mid-size medical device companies,” says Jozef Kovac, owner of MDRC.

“We give clients a nuanced lens to understand their current stance and help prevent issues that lead to costly compensations.”

MDRC’s Slovakian-based team of contracted doctors from ophthalmology, anesthesiology, gastroenterology, intensive care medicine, and cardiology domains actively participate in clinical evaluations and usability and preclinical studies. For regulatory assessments, the team conducts comprehensive evaluations of a client’s processes and systems to identify compliance gaps and areas for improvement. MDSAP, MDR, and ISO gap analysis are then performed to identify existing bottlenecks, helping them script policies and procedures to better align with mandated standards. This multifaceted, agile strategy enables organizations to take a proactive approach to regulatory adherence through risk assessments, contingency planning, and engaging with regulators early on instead of waiting for set audit timelines.

On the quality assessment side, MDRC offers auditing services based on MDR 2017/745, 21 CFR Part 820 requirements and ISO 13485:2016 standards. The team examines all quality systems, evaluates preparedness for upcoming external audits, and offers valuable support during the audit processes, facilitating confidence in regulatory adherence.

It also lends a hand in creating and optimizing technical documentations for medical devices for the 510k submission and CE certification. One of its prominent offerings is preparing CER reports according to the MDR 2017/745 requirements, MEDDEV 2.7/1 Rev 4 and MDCG guidelines, which encompasses conducting clinical literature searches to guarantee reporting accuracy. The team provides regulatory post-market surveillance reviews, ensuring ongoing compliance and safety in the post-market phase of medical devices or products.

“Apart from compliance strategy development, we specialize in delivering highly targeted and niche training programs, often overlooked by others in the industry,” says Mr. Kovac.

MDRC offers training in MDSAP, 510k submissions, clinical evaluation, biocompatibility, process validation, and usability of medical devices. Its location in the Central European region and commitment to small overheads, positions the company to assist clients across the continent. MDRC’s high-quality, low-cost services have helped renowned names in the industry, including QMD, OXYMAT, Dräger, and Unimed Pharma.

In the days ahead, MDRC aims to expand its service footprint. It’s not an exaggeration to say that MDRC is at full-throttle to become the preferred compliance consultant for medical device regulatory affairs within Central Europe.