Meet the Founder

About Me — ARKA Regwriting Ltd

Hi, I'm Manohar Gangula, a Medical Device Regulatory Affairs and Clinical Evaluation professional with over 10 years of experience supporting the development, regulatory compliance, and lifecycle management of medical devices. My passion is ensuring that safe, effective, and compliant medical devices reach patients through robust scientific evidence, regulatory excellence, and cross-functional collaboration.

My Background

I have built my career across the medical device industry, specialising in Clinical Evaluation Reports (CERs), Technical Documentation, EU MDR compliance, Post-Market Clinical Follow-up (PMCF), Post-Market Surveillance (PMS), Risk Management, and global regulatory submissions. I have authored and reviewed more than 60 CERs and associated regulatory documents, working with leading global medical device companies and multidisciplinary teams to deliver documentation that meets international standards and supports successful product approvals.

My earlier career in clinical safety gave me a strong foundation in clinical evidence: I worked on safety activities including patient narrative writing, case processing, and MedDRA coding to support adjudication of events against clinical trial endpoints — experience that continues to strengthen my critical appraisal of clinical data today.

My Expertise

My expertise includes interpreting and applying the requirements of the EU Medical Device Regulation (MDR 2017/745), MEDDEV 2.7/1 Rev. 4, ISO 14971, ISO 13485, and other applicable regulatory frameworks. I have extensive experience preparing and reviewing Clinical Evaluation Reports, analysing clinical and scientific literature, evaluating clinical evidence, and supporting Notified Body submissions for a wide range of medical devices.

Clinical Evaluation & Post-Market Support

• Clinical Evaluation Reports (CERs) — authoring, updating, and remediation to MEDDEV 2.7/1 Rev. 4 and EU MDR requirements
• Clinical Evaluation Plans (CEPs) and literature search protocols
• Systematic literature searching, screening, and critical appraisal of clinical evidence
• State-of-the-art reviews and equivalence assessments
• Post-Market Clinical Follow-up (PMCF) plans, surveys, and evaluation reports
• Post-Market Surveillance (PMS) plans and reports, including PSURs

Technical Documentation & Submissions

• End-to-end technical file preparation and remediation for EU MDR compliance
• GSPR checklists — preparation, gap analysis, and evidence mapping
• Risk management files to ISO 14971, including hazard analysis and benefit-risk determinations
• Instructions for Use (IFU) and labelling — drafting, reviewing, and compliance verification
• Notified Body submission support, including responses to questions and nonconformities

Design & Development Documentation

• User needs and design input documentation
• Design review support and documentation
• Design verification and validation (V&V) planning and reporting
• Design transfer documentation
• Design history file (DHF) compilation and gap assessment

Training & Professional Development

• Clinical evaluation methodology under EU MDR, MEDDEV 2.7/1 Rev. 4 and MDCG guidance
• Literature searching and critical appraisal techniques
• CER structure, writing, and common Notified Body findings
• Technical documentation and GSPR compliance
• Practical, hands-on guidance from real-world submission experience

Skills & Professional Development

Throughout my career, I have developed strong skills in technical writing, critical appraisal of clinical evidence, gap analysis, regulatory strategy, and project coordination. I am committed to continuous professional development and staying up to date with evolving global regulatory requirements and industry best practices.

Education

• Master's degree in Molecular Pathology — London, UK
• Diploma in Clinical Research

My Philosophy

I believe that well-prepared clinical and regulatory documentation plays a vital role in bringing innovative medical technologies to market and improving patient outcomes. I take pride in delivering high-quality work, building collaborative relationships, and supporting organisations in achieving regulatory compliance with confidence.

My goal is to continue contributing to the medical device industry through ARKA Regwriting Ltd — providing expert regulatory and clinical evaluation support that enables innovation while maintaining the highest standards of safety, quality, and compliance.