ROI MedTech provides people-first expertise to medical device innovators, from start-ups to established firms, helping them overcome regulatory, clinical, product development, and quality management challenges across North America, Europe, and APAC regions.
Services
Regulatory Strategy & Execution
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Our experts develop and drive your FDA strategy, including Q-Submission packages and leading FDA meetings. We create, submit, and own 510(k), De Novo, Breakthrough Designation, IDE, HDE, and PMA applications for all device types, including paediatric, implantables, wearables, SaMD, AI, and medical software.
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European CE Mark (EU MDR 2017/745 and EU 2017/746): Our expertise includes EU MDR Technical Documentation and Clinical Evaluation development for Class IIa, IIb, and III devices. We lead the interactive review processes with EU Notified Bodies (e.g., BSI, Intertek, TUV, etc).
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We develop regulatory strategies and handle submissions for devices of all risk classes in major global markets including USA, Canada, Australia, UK, and others.
Clinical Study Design & Evaluation
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We design efficient and compliant clinical protocols to gather the data needed to fulfil your specific market entry strategy.
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We develop "minimally viable" trial strategies and lead early regulatory engagements to de-risk clinical studies and ensure it aligns with your commercialization planning.
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Our team works in tandem with Clinical Research Organizations to successfully execute pre-clinical, first-in-human, pilot, and pivotal studies at all scales.
Product Development & Pre-Clinical Support
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Our experts lead your team through product development in compliance with key international standards and regulations, from product planning through design inputs & traceability, verification & validation planning, testing, and reporting, and design transfer to production either in-house or with manufacturing partners. We ensure every step works in tandem with your regulatory and broader commercialization strategies.
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We develop critical design inputs including Risk Management Files per ISO 14971, Human Factors/Usability Engineering Files per IEC 62366-1 and FDA Guidances, Biological Evaluation Plans and Reports per ISO 10993-1, Software Development & Maintenance Plans, Verification & Validation Plans, etc.
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We manage critical external testing processes performed by qualified third-party labs on your behalf, including but not limited to electrical safety & EMC, battery certification, laser safety, biocompatibility, sterilization validation, packaging, stability & shelf life, etc.
Quality Management & GMP
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We establish and support your ISO 13485:2016, FDA QMSR, EU MDR, and MDSAP-compliant QMS for companies of all sizes, from <4 to over 70 employees.
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We conduct internal & supplier audits and support certification & surveillance audits, and provide ongoing Quality Operations Consulting for processes like CAPA, NC, and ECO management.
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We handle Contract Manufacturer qualification and management, including written quality and manufacturing agreements, and facilitate Design Transfer to Production between manufacturers and CMOs.
Partners
Abhiram Pushparaj, PhD
With over 15 years in the medical device industry as a start-up founder and VP Clinical & Regulatory, Abhi brings a deep background in regulatory affairs and R&D. He has extensive experience engaging and negotiating with FDA, EU, and Health Canada Reviewers across a range of devices to secure efficient and timely approvals, including Class III implants, combination products, and paediatrics.
Aparajit Sahai, MASc
Aparajit has over 10 years of experience in engineering, quality, and regulatory leadership as Quality Manager and Regulatory Consultant. He has worked on a range of devices, from digital health and SaMD (Software as a Medical Device) to surgical instruments and robotic systems. He brings an extensive background in strategic regulatory affairs and product development, as well as quality management leadership and auditing.
Martin Musiol, RAC, CMDA
Martin has over 10 years of experience serving in Senior Consultant, Director, and Fractional roles, leading cross-functional teams at start-ups and mid-sized medtech companies to achieve critical milestones and scale. He specializes in developing efficient and compliant regulatory and product development strategies that bridge the gap between technical vision and commercial reality across North America, Europe, and APAC.
Contact Us
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