Why Choose Qualisure Consulting
At Qualisure Consulting, we are dedicated to helping organisations navigate the intricate world of medical device regulations and quality management. Whether you’re developing SaMD solutions or other medical technologies, our expertise in multi-jurisdictional regulatory conformity, risk assessment, and quality systems can provide the guidance needed to bring your innovations to market efficiently and compliantly.
We are passionate about driving innovation in healthcare technology and collaborating with professionals who share a vision for improving patient care through advanced medical software solutions. Let’s work together to shape the future of healthcare.
Deep Technical Expertise
Backed by extensive experience as a BSI regulatory auditor and senior regulatory affairs professional, we deliver practical, audit-ready solutions that meet notified body and competent authority expectations.
Tailored Implementation Approach
Every engagement begins with comprehensive gap analysis and risk assessment, followed by customized implementation plans with clear milestones, deliverables, and timelines specific to your device classification and regulatory pathway.
End-to-End Project Management
From initial scoping through certification audit, we provide hands-on support including documentation development, staff training, process optimization, and ongoing compliance monitoring.
Industry-Focused Results
Our consulting methodology emphasizes conversion-driven outcomes: achieving certification, securing market authorization, and establishing sustainable quality systems that support business growth.
Our Approach
Assessment & Strategy – Comprehensive evaluation of your current state, regulatory requirements, and business objectives to develop targeted compliance strategies
Documentation & Implementation – Creation of quality manuals, SOPs, risk management frameworks, and technical documentation aligned with ISO 13485 and MDR/IVDR requirements
Training & Capability Building – Structured training programs to develop internal competence and ensure sustainable quality system maintenance
Audit Support & Certification – Internal audit preparation, corrective action management, and certification body liaison to achieve successful outcomes
Industries Served
- Active medical devices (Class IIa, IIb, III)
- Software as a Medical Device (SaMD)
- In vitro diagnostic devices
- Connected medical devices and sensor technologies
- Emerging medical technology companies
Get Started
Contact Qualisure Consulting to discuss how our regulatory affairs and quality management expertise can accelerate your path to compliance and market access. We deliver practical solutions that meet regulatory requirements while supporting your commercial objectives.
Meet the Managing Director
With over two decades of experience in medical device technology, Qualisure Consulting is headed up by Carlos Maline, who brings a unique combination of leadership, technical expertise, and regulatory knowledge to the rapidly evolving healthcare industry.
His career journey spans 19 years in the Royal Air Force, where he honed his skills in precision and discipline, followed by a tenure as Senior Client Manager at BSI, gaining invaluable insights into regulatory compliance and quality management systems. Most recently, as Senior Regulatory Affairs Specialist, Carlos is at the forefront of revolutionising healthcare through innovative Software as a Medical Device (SaMD) solutions.