Who We Are
We are a leading consultancy firm specialising in regulatory and quality services for medical devices. Our team of seasoned experts is dedicated to guiding you through every step of the regulatory process, ensuring your products meet the highest standards of safety and efficacy.
Simplifying Regulatory Compliance for SMEs
At our consultancy, we specialise in making regulatory compliance straightforward for small and medium-sized enterprises. Our services are:
- Tailored to Your Needs: We customise our approach to fit your specific requirements.
- Cost-Effective: Competitive rates that provide value without compromising quality.
- Comprehensive Expertise: Full support throughout the entire medical device regulatory approval cycle.
Why choose us?
1. Comprehensive Regulatory Support
UKCA, FDA, EU, and global regulatory submissions
CE marking and MDR compliance
Pre-market approval (PMA) and 510(k) submissions
Risk management and post-market surveillance
2. Quality Assurance Excellence
ISO 13485 certification assistance
Quality management system (QMS) implementation
Internal audits and gap analysis
CAPA (Corrective and Preventive Action) processes
3. Customised Solutions
- Tailored strategies to fit your unique needs
- In-depth training for your team on regulatory and quality requirements
- End-to-end project management from concept to market launch
4. Proven Track Record
- Decades of combined industry experience
- Successful approvals for a wide range of medical devices
- Trusted by startups and established companies alike
Founder: Mary Patricia Ryan
Mary Ryan, Executive Director Medical Device Business Leader / Multi Award Winning Quality Assurance & Regulatory Affairs Expert / Keynote Speaker / Consultancy/ Change Maker / Market Access/ Board Member / Mento
Mary Ryan is an award-winning Medical Device Quality and Regulatory Professional who spearheaded the Development and Regulatory Lead for the NHS Ventilator Challenge (VCUK), showcasing her leadership in times of national critical need. Mary is a distinguished professional in the medical device sector, renowned for her expertise in Quality Assurance and Regulatory Affairs (QARA). With a career spanning nearly three decades, Mary has become an influential force in shaping the landscape of medical technology and regulatory frameworks on a global scale.
Mary’s professional journey began in the technical fields of plastic injection moulding and electronics manufacturing. Through her career, she has led numerous high-impact projects, including pivotal contributions to vocational educational programs, the development of certification programs for the Dental and Cosmetics industries, and the management of multi-million-dollar medical device outsourcing initiatives.
Key Skills
- Quality Assurance
- Quality Management Systems
- Global Regulatory Affairs
- Business Strategy
- Motivational Speaking
- PRRC
- UKRP
Languages
- English (Professional)
- Mandarin (Professional)
- Tamil (Professional)
- Telugu (Professional)
- Filipino (Professional)
- French (Conversational)
- Spanish (Conversational)
- Turkish (Conversational)
- British sign language (Elementary)
- Irish sign language (Professional Working)