In today's global marketplace, the development and marketing of medical products is highly regulated with strict governmental requirements both domestically and internationally. Since 2001, Lincé Consulting has provided Regulatory, Clinical, and Quality consulting services to help medical product manufacturers meet those requirements. Our team has extensive FDA, global government, Notified Body, industry, and healthcare experience and a thorough understanding of product development and testing, governmental approval processes, and compliance and quality assurance systems.
Hiring an expert by the project, hour or day optimizes your efficiency because you can focus on what you do best and leave the rest to us. Our experienced professionals can quickly answer and address your regulatory, clinical and quality questions and needs. Any size organization or project can benefit from our expertise and we'll help you navigate through the myriad of US and international regulatory mazes in the most efficient pathway possible. Lincé Consulting has successfully provided Regulatory, Quality and Clinical services to a broad range of clients from small start-up companies to large established corporations. We are well versed in the various regulatory, quality and clinical requirements and compliance conditions applied to medical products worldwide and our team is dedicated to establishing the most practical solutions to meet client milestones in the most efficient and cost effective way possible, from concept through post-marketing.
- Vast knowledge and utilization of IDE, 510K, PMA, IND, NDA, cGMP/QSR, ISO, GLP, GCP, MDD/R, IVD/R and various international regulations and requirements.
- Extensive experience working with FDA and international regulatory agencies to obtain marketing clearances/approvals.
- Due diligence for potential investment opportunities.
- Creative strategy development skills to get your product to market in the shortest possible time.
- Clinical trials design and management in both the US and international markets.
- Extensive experience in working with domestic and international regulatory agencies to obtain and maintain compliance.
- Proven development and implementation skills.
- Trained Quality Systems Auditors for cGMP, QSR and ISO compliance.
- Regulatory, Clinical and Quality experience in various applications and technologies, including but not limited to:
◦ General Surgery/Laparoscopy
◦ Gynecology /Infertility/Women's Health
◦ Cardiac Surgery
◦ Wearable Sensors
◦ Tissue Markers
◦ Wound Closure
◦ Vascular Closure
◦ Vascular Disease
◦ Trans-dermal Drug Applications
◦ Dermatologic Applications
◦ Biometric Monitoring
◦ Combination Products