Traditionally, medical device innovators have had to hire separate niche consulting firms for regulatory strategy, specialized CROs for clinical trials, and separate agencies for reimbursement planning. This siloed approach often leads to disconnected strategies, data gaps, and costly launch delays. By uniting MCRA’s premier advisory specialization with IQVIA MedTech’s global footprint and data-driven infrastructure, you get a single, cohesive partner. We align your clinical evidence generation, global regulatory submissions, and downstream payment pathways from day one, significantly accelerating your time-to-market.
Not at all. Our integrated model is built to scale and support innovators of all sizes—from early-stage, venture-backed startups with a single disruptive technology to established global multinational enterprises. We customize our team assemblies and solutions to match your specific timeline, budget, footprint, and internal capacity gaps.
Our unified organization features deep,
specialized therapeutic expertise across more than 15 key medical device and diagnostic verticals. This includes extensive portfolios in high-risk and complex areas such as Orthopedics/Spine, Cardiovascular, Neurological, General Surgery, Wound Care, Aesthetics, In Vitro Diagnostics (IVD), and Digital Health/Software as a Medical Device (SaMD).
Yes. This is a core advantage of our integration. We combine specialized, hands-on study design with IQVIA MedTech's world-class clinical research organization (CRO) legacy and global operational infrastructure.
Our advisory team includes more than 25 former FDA officials, Notified Body reviewers, and international regulatory authorities embedded directly into our practice. They review your data, dossiers, and submission strategies with the exact mindset of a regulatory auditor. This insider perspective allows us to pre-emptively identify potential pushbacks, optimize your testing protocols, and build highly compliant submissions for FDA (510(k), De Novo, PMA), EU MDR/IVDR, and UKCA pathways.
We provide global coverage, combining deep US FDA and European MDR/IVDR expertise with localized, bilingual regulatory footprints across key APAC and international markets.
Securing regulatory clearance or approval does not guarantee commercial success. If healthcare providers cannot code for your device, if insurance payers do not offer coverage, or if the reimbursement payout is too low to cover your margins, your product will fail in the market. By integrating reimbursement consultants into the early clinical and regulatory design phases, we ensure that your clinical trials gather the exact health economics and outcomes data (HEOR) that insurance payers need to see to grant favorable coverage from day one.
