Whether you need help preparing a Clinical Evaluation Report, compiling a 510(k) submission, or building a compliant quality system, PM Consultants Inc is here to support you at every stage of the regulatory journey.
We work with clients across the globe—from early-stage startups to established medical device manufacturers—offering flexible, responsive, and high-quality consulting and documentation services.
We offer:
Medical Writing: CERs, CSRs, Lay Summaries, Clinical Protocols, etc.
Regulatory Consulting: 510(k) submissions, Technical Files, Design Dossiers, PIP/PSP, and more
Quality System Support: ISO 13485 documentation, SOP development, Risk Files, QMS consulting
Yes, we provide comprehensive support for 510(k) applications to the US FDA and CE Mark documentation under the EU MDR, including Clinical Evaluation Reports (CER), Technical Files, and Post-Market Surveillance (PMS) plans.
Our team includes highly skilled medical writers, regulatory consultants, and quality system professionals with years of experience in the MedTech industry. All documents go through rigorous internal review and quality control before delivery.
Timelines vary depending on the scope of the project. For example:
A CER may take 2–4 weeks
A 510(k) application may take 4–8 weeks
Smaller documents like Lay Summaries or Briefing Books can be delivered faster
We also offer accelerated delivery options for urgent regulatory needs.
At PM Consultants we are a group of dedicated medical writers, regulatory affairs professionals, clinical researchers, and quality
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