Having an experienced medical writing partner is invaluable when identifying and organizing medical device data to achieve regulatory goals and objectives. NAMSA provides a myriad of medical writing services to assist global Sponsors with specialized report and manuscript writing, evidence communication services and solutions to comply with MDR, IVDR, MEDDEV 2.7.1 rev. 4 and other global regulatory requirements.
When working with NAMSA, Clients receive the benefit of our cross-functional expertise and knowledge. NAMSA’s medical writers work alongside our Biostatistics, Clinical and Regulatory Teams to organize, interpret and present data in an accurate and professional manner that is highly recognized and trusted by global regulatory entities. In addition, our experts help take the guesswork out of future medical writing requirements and can provide Sponsors personalized plans to address upcoming compliance activities and processes.
And—most importantly—when you partner with NAMSA, you maintain project control while gaining the benefit of on-demand external support-whether the goal is to extend your in-house capabilities or obtain access to the specialized expertise you need.
Contact us today to learn about our medical writing and regulatory support services including:
- Clinical Evaluation Reports (CERs), Early Stage, New Submission and Maintenance Updates
- Instruction for use (IFU), User Guide/Labeling
- Periodic Safety Update Reports (PSUR)
- Summary of Safety and Clinical Performance (SSCP)
- Implant Cards
- Periodic Benefit-Risk Evaluation Reports (PBRER)
- Grant proposals for research scientists and academic institutions
- Competitive Surveillance Information
- Creation and/or Peer-review of abstracts, academic or research articles, posters, manuscripts, and presentations
- Post-Market Clinical Follow-Up Strategy and Report Support
- Clinical Benefit/Performance Claims Assessment Support
- Risk Management Plan (RMP) Support
+1 866.666.9455 (toll free)
+1 419.666.9455 (outside of USA)