P&L Scientific
P&L SCIENTIFIC INC is a professional medical device regulatory compliance and market consultancy company, providing services in international registration, regulatory affairs, and market analysis for medical devices, in vitro diagnostic reagents, and related products. With offices in Miami, USA, and Beijing, China, the company helps clients achieve faster product registration and market entry through local and international regulatory expertise. They are members of the Regulatory Affairs Professional Society (RAPS) and have served numerous clients including major medical device manufacturers and healthcare groups since 2009.
Industries
Nr. of Employees
small (1-50)
P&L Scientific
Coral Gables, Florida, United States, North America
Services
Consulting services covering establishment registration and device listing, 510(k) submissions, U.S. agent representation, and QSR compliance support.
Support for CE marking, preparation of technical files/design dossiers, ISO 13485 compliance, and acting as European authorized representative.
Assistance with CFDA/NMPA approvals, CCC marking, medical device production license processes, clinical trial coordination, and standards drafting for China market entry.
Design and operational management of clinical studies and trials for device regulatory submissions.
Market capacity analysis, healthcare policy and reimbursement analysis, distributor search and qualification, and trade show support for market entry.
Coordination of device testing services and involvement in drafting applicable medical device standards.
Consulting services covering establishment registration and device listing, 510(k) submissions, U.S. agent representation, and QSR compliance support.
Support for CE marking, preparation of technical files/design dossiers, ISO 13485 compliance, and acting as European authorized representative.
Assistance with CFDA/NMPA approvals, CCC marking, medical device production license processes, clinical trial coordination, and standards drafting for China market entry.
Design and operational management of clinical studies and trials for device regulatory submissions.
Market capacity analysis, healthcare policy and reimbursement analysis, distributor search and qualification, and trade show support for market entry.
Coordination of device testing services and involvement in drafting applicable medical device standards.
Expertise Areas
- Medical device regulatory affairs (US, EU, China)
- Clinical trial design and management for devices
- Quality management systems (ISO 13485, FDA QSR)
- Market access and commercialization strategy
Key Technologies
- Regulatory submission processes (510(k), CE technical file, CFDA/NMPA filings)
- Clinical study design and management
- Quality management system implementation (ISO 13485, QSR)
- Technical dossier and design dossier preparation
News & Updates
2011年3月1日
2011年3月1日
2011年6月10日
2011年10月23日
2012年5月14日
2012年11月14日
2011年3月1日
2011年3月1日
2011年6月10日
2011年10月23日
2012年5月14日
2012年11月14日