We provide specialized consultancy services for the structured implementation of Quality Management Systems (QMS) based on MDSAP, ISO 13485, ISO 9001, ISO 14001, and ISO 45001 standards. Our methodology encompasses initial assessments, customized system development, documentation support, training, internal audits, and preparation for certification audits. By aligning with international best practices and regulatory requirements, we assist organizations in strengthening operational efficiency, regulatory compliance, and risk management across all levels. Our commitment is to deliver sustainable value, ensuring your organization achieves and maintains certification with confidence and precision.
Design & Development Documentation
Get your medical device innovations to market faster and with full confidence! Our consultancy services specialize in building Design and Development Documentation that meets ISO 13485 and 21 CFR 820.30 standards. From design planning and risk management to verification, validation, and design transfer, we ensure every step is compliant, clear, and audit-ready. Our team works closely with yours to streamline the process, reduce regulatory hurdles, and support faster, safer product launches — all while ensuring the highest standards of quality and patient safety. Partner with us to bring your ideas to life with precision and compliance.
- Clinical Evaluation Report (CER)
- Risk Management & Usability Engineering
- Electro compatibility Report Review
- BIS Certification for Domestic Manufacturer (ISI Mark)
