Need support with CER, PMS, PMCF or EU MDR strategy? Need to move your RA career forward? Need an expert to write LinkedIn posts or newsletters for you in RA? Reach out — I'd be happy to help.
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Happy to connect and collaborate with MedTech teams working towards safe, effective and compliant devices.
FAQs
Simply contact me through the enquiry form or email me with your project details. I'll get back to you with all the required information within 1–3 working days.
Support is provided primarily with the European Medical Device Regulation (EU MDR 2017/745), FDA regulations, and CDSCO quality and regulatory requirements. I also assist with documentation aligned to global regulatory expectations, where applicable.
Yes. Early regulatory planning can significantly reduce delays, unnecessary studies and documentation gaps later for the manufacturer. This approach is highly appreciated across the medical device lifecycle to save considerable time and cost.
Yes. Many manufacturers already have Clinical Evaluation Reports that require updating or strengthening before submission or Notified Body review. Rather than rewriting unnecessarily, the focus is on improving the quality and regulatory robustness of your existing documentation.
Yes. Responding effectively to Notified Body observations requires a deep understanding of the regulatory intent behind each comment — an expertise I bring to every response.
Yes, I quite often integrate my existing process to support and complement existing client processes for smooth execution.
Yes. I offer customized workshops and training programs covering Clinical Evaluation Reports (CER), literature reviews, PMS, PMCF, benefit-risk evaluation, regulatory writing, and the practical implementation of EU MDR requirements — for both individuals and organizations.
I offer services individually and also in packages. Please send me your requirement and I'll get back to you with a feasible quote within 1–3 working days.
Absolutely. I am pleased to sign your company's NDA before receiving any documentation. If required, I can also provide my own mutual confidentiality agreement. All project information is handled with strict professional discretion.
