Our Services
QMS serves as a one-stop solution for all your compliance, quality, and product development needs in the medical device industry. We specialize in regulatory and quality support for both traditional medical devices and Software as a Medical Device (SaMD), ensuring end-to-end compliance throughout the product lifecycle.
Capabilities
QMS is dedicated to helping medical device companies achieve regulatory compliance, uphold the highest quality standards, and streamline product development. With expertise in both traditional medical devices and Software as a Medical Device (SaMD), we simplify complex regulatory challenges while fostering innovation and security. Our end-to-end solutions ensure that businesses can confidently bring their products to market, meeting global regulatory requirements without delays. With a commitment to excellence, we deliver a seamless compliance journey, guaranteeing 100% first-time certification success.
Beyond compliance, QMS provides Product Development Support, guiding businesses through every stage of the product lifecycle—from concept to commercialisation. Our experts assist in designing, testing, and validating medical devices and software, ensuring that they meet both technical and regulatory requirements. By integrating quality and regulatory considerations from the outset, we enable faster approvals and market access.
Comprehensive SaMD Services
1
Regulatory and Compliance Services
Navigate the complexities of global medical device regulations with our comprehensive services
- ISO 13485 certification preparation for medical devices and SaMD
- FDA 510(k), PMA, and CE marking submission assistance.
- EU MDR and IVDR compliance for Class I, II, and III devices.
- Software lifecycle documentation compliant with IEC 62304.
- Risk management compliance (ISO 14971) for both hardware and software devices.
- Cybersecurity compliance tailored to FDA, IEC/TR 60601, and global regulatory requirements.
- AI/ML-specific compliance guidance (Good Machine Learning Practices - GMLP).
2
Quality Management Services
Implement best-in-class quality management systems for medical devices and SaMD with eQMS:
- End-to-end eQMS implementation, customization, and integration.
- CAPA (Corrective and Preventive Actions) tracking and management.
- Document control, training management, and versioning.
- Supplier qualification and ongoing risk management.
- Internal and external audit preparation and execution.
- Post-market surveillance and vigilance support for compliance.
3
Product Development Support for Medical Devices and SaMD
From concept to commercialization, we provide technical and regulatory support to ensure compliance and innovation:
- Comprehensive product design and development consulting for hardware and software devices.
- Verification and validation (V&V) testing, including usability, performance, and biocompatibility for hardware.
- SaMD-specific services such as algorithm validation and cybersecurity integration.
- Support for connected healthcare devices, telehealth, and digital health platforms.
- Post-market surveillance and vigilance support for compliance.
4
IT and Cybersecurity Solutions
Ensure your devices are secure and compliant in today’s digital health landscape:
- Cybersecurity risk assessment and mitigation strategies.
- Data integrity and privacy compliance with GDPR, HIPAA, and global standards.
- Secure digital health solutions, including mobile health apps and remote monitoring systems.
- Implementation of cybersecurity features for connected medical devices.
5
Documentation and Technical Writing
Streamline your regulatory submissions with robust documentation services:
- Creation and maintenance of technical files and Design History Files (DHF).
- Preparation of Clinical Evaluation Reports (CERs) for MDR/IVDR compliance.
- Development of risk management files and traceability matrices (ISO 14971).
- Post-market surveillance reports and periodic safety updates.
6
Training and Advisory Services
Equip your team with the tools and knowledge to succeed in a highly regulated industry:
- Custom training programs on quality management, risk management, and regulatory standards.
- Workshops on cybersecurity, AI/ML compliance, and SaMD development best practices.
- Advisory support for emerging trends in connected healthcare and digital health.
