Director, Founder & Principal Consultant
Manohar Gangula
10+ years in medical device regulatory affairs and clinical evaluation. Author of 60+ CERs with direct Notified Body submission experience.
View profile →Expertise
Our team
Regulatory writers and clinical evaluation specialists who work as an extension of your quality, R&D, and regulatory teams.
People
Specialists behind every deliverable
Team profiles and photos can be updated as ARKA grows. Each consultant brings direct medical device documentation experience.
Senior Consultant
Regulatory Writer
Specialises in technical file preparation, GSPR mapping, and risk management documentation under EU MDR and ISO 14971.
Consultant
Clinical Evaluation Specialist
Focuses on literature searching, critical appraisal, state-of-the-art reviews, and PMCF plan development for Class IIa–III devices.
Consultant
Design Controls Consultant
Supports design history files, V&V planning, and design transfer documentation aligned to ISO 13485 and MDR Annex requirements.
Need a dedicated documentation team?
Tell us your device class and timeline — we will assemble the right regulatory writing and clinical evaluation support.
Contact ARKA