Medical Device Innovation
MedStrategist provides expert consultancy in Medical Device Regulatory and Quality Management, specializing in implementing systems for compliance, sustainability, and growth through strategic, cutting-edge frameworks, with a focus on knowledge transfer through training.
Comprehensive Expertise
in the Medical Device Industry
At MedStrategist, led by S L Sriram, we excel in managing complex projects within the medical device sector. With a proven track record, we specialise in implementing practical, effective strategies at the operational level, which has contributed to our long-standing success in the field.
S L Sriram MedStrategist Services
QMS Implementation
Implementing a Quality Management System (QMS) for medical devices demands a focused approach on safety and performance, given the direct impact these devices have on human health. MedStrategist ensures a sustainable, client-empowered QMS implementation, avoiding a mere template-based approach. We tailor the ISO 13485 standard to match the organization’s roles and the type and category of medical devices involved.
With experience across a broad spectrum of product types—Active, Non-Active, IVD, Software as a Medical Device (SaMD)—MedStrategist offers highly specialized implementation for diverse organizations, covering everything from invasive and non-invasive devices to IoT and software.
Regulatory Compliance
Our regulatory compliance strategy follows a step-by-step process, integrating with the QMS at every stage—from concept and design to manufacturing and post-market activities. Our services include:
Our Expertise
Product Development & Innovation
Under the leadership of S L Sriram, MedStrategist has contributed to the development of eight medical devices spanning diagnostic, therapeutic, and imaging categories. Notably, Mr. Sriram developed a pioneering IoT device that earned seven international awards for innovation in design and technology.
Manufacturing and Technology Transfer
We provide end-to-end guidance for establishing manufacturing setups, from technology selection and transfer to product realization and operational oversight. Our experience includes four successful technology transfers and the establishment of three manufacturing units.
Regulatory & Quality Expertise
MedStrategist offers deep expertise in global regulatory approvals and Quality Management Systems. We specialize in ISO 13485, ISO 9001, ISO 14971, IEC 60601, IEC 62304, IEC 62366, EU-MDR, EU-IVDR, and Indian MDR-CDSCO.
Training & Development
We offer comprehensive training programs tailored to various organizational levels, covering products, technology, processes, and regulatory standards. Our training ensures that teams are well-versed in the medical device industry.
About S L Sriram
S L Sriram, the driving force behind MedStrategist, brings over 43 years of experience in the medical device industry. His extensive career spans roles in sales, service, product development, and project management.
About S L Sriram
Director – Product Development & Strategy