MEDICAL DEVICES & IN VITRO DIAGNOSTICS
End-to-end regulatory consulting services designed to support medical device and in vitro diagnostic (IVD) manufacturers in achieving and maintaining compliance across global markets. Medical device and IVD programs move faster when regulatory, quality, clinical, and commercial teams are working from the same plan. ProConXol helps manufacturers clarify the pathway, prepare the evidence and documentation, strengthen quality systems, and manage ongoing obligations across the product lifecycle.
Discuss Your Medical or IVD DeviceA PRACTICAL STARTING POINT
The right approach depends on intended use, risk, technology, claims, existing evidence, and where you plan to market. We begin with those fundamentals, then build a scope that fits your stage—whether you are evaluating a concept, preparing a submission, responding to an audit, or maintaining a marketed product.
HOW WE CAN HELP
Clarify product classification, jurisdiction, likely submission route, evidence expectations, and key decision points. Support may include U.S. 510(k), De Novo, PMA, EUA when applicable, FDA pre-submission planning, EU MDR or IVDR strategy, and selected international pathways.
Prepare, review, and coordinate submission content; organize supporting records; manage questions and commitments; and support meetings or correspondence with the relevant health authority.
Develop, improve, or remediate a quality management system aligned to applicable requirements, including FDA’s QMSR in 21 CFR Part 820 and ISO 13485:2016. Work may include SOP development, document control, training, supplier controls, CAPA, internal audits, and management review.
Create or strengthen the documents that connect product requirements, design and development, risk management, verification and validation, clinical evidence, manufacturing, and post-market activities.
Review labels, instructions for use, packaging, UDI elements, websites, and promotional materials for consistency with intended use, cleared or approved claims, and applicable market requirements. Support also includes submission of CLIA categorization applications to FDA for private labeling of IVD devices.
Build practical processes for complaints, adverse-event and vigilance reporting, trend review, corrections and removals, recalls, periodic reporting, and post-market clinical follow-up where required.
Strengthen audit readiness and confidently manage regulatory inspections with expert support for FDA inspections, Notified Body audits, MDSAP audits, and partner assessments. Services include regulatory gap assessments (FDA, MDSAP, EU MDR/IVDR), mock audits, audit preparation, responses to regulatory observations, root cause analysis, and CAPA support.
Support manufacturing licenses and regulatory registrations to help ensure uninterrupted operations and market access. Services include FDA Establishment Registration and Device Listing, EU economic operator registrations, state licensing, renewals, change notifications, and other jurisdiction-specific market maintenance activities.
Support compliant global trade of medical devices and IVDs through FDA and USDA import guidance, permit support, detention resolution, and preparation of export certificates (FSC, CoE, CFG) and market-specific documentation.
Access experienced regulatory professionals through flexible remote staffing solutions tailored to your project needs and business requirements. We provide contract-based hourly, fixed-rate, part-time, and full-time regulatory personnel, significantly reducing the cost and commitment of traditional hiring.
WHY IT MATTERS
Expect a written plan that identifies deliverables, owners, dependencies, decision points, and review cycles—with attention directed first to issues that may affect safety, performance, data integrity, submission quality, or continued market access.
COMMON QUESTIONS
Support can include U.S. 510(k), De Novo, PMA, applicable FDA interactions, EU MDR and IVDR activities, and selected global registrations. The exact scope depends on the product and jurisdiction.
Yes. We can assess existing processes, identify gaps, update procedures and records, support implementation, train teams, and prepare for inspection under the current QMSR framework.
Yes. Engagements can range from a targeted document review to end-to-end coordination. We define interfaces and assumptions clearly when responsibilities are shared across teams.
No. FDA, Notified Bodies, and other authorities make those decisions. We help teams select an appropriate strategy, develop clear documentation, and respond effectively throughout the process.
LET’S MOVE FORWARD
Share your device type, target market, development stage, and most urgent milestone. We will help define the work needed to move forward with greater confidence.
