Massachusetts Technology Innovation
Massachusetts Technology Innovation (MTI) is a Boston-based company dedicated to creativity and diversity in Life Science, Information Solutions, Medical Devices, and AI Compliance. Founded in 2015 by Octavian Boca, MTI offers strategic advisory, systems implementation, regulatory compliance, and software development services to help pharmaceutical, biotech, and med-device companies thrive in the modern business world. With a focus on innovation, sustainability, and client success, MTI provides expertise in AI/machine learning compliance, medical devices, cloud governance, and managed IT services.
Industries
Nr. of Employees
small (1-50)
Massachusetts Technology Innovation
Boston, Massachusetts, United States, North America
Products
No-code Part 11 QMS platform
A no-code platform designed to create and automate Part 11‑aligned quality management and compliance processes, and to assess AI practices against relevant guidance and regulation.
No-code Part 11 QMS platform
A no-code platform designed to create and automate Part 11‑aligned quality management and compliance processes, and to assess AI practices against relevant guidance and regulation.
Services
Advisory services for startups and mid-size life-science organizations covering QMS implementation, process improvements, SaaS governance, IT compliance, audits and regulatory remediation.
Ongoing managed services including audit readiness, audit support, internal audit and periodic review, and CRO/CMO vendor qualification.
Requirements gathering, software design and development, testing and implementation of cloud or on-premises systems; automation of compliance workflows using no-code platforms.
Cloud platform qualification, cloud software validation, release and change management, and validation support including IQ/OQ/PQ activities.
Support for medical device companies on regulatory compliance with Quality System Regulation (QSR, 21 CFR Part 820), design controls, risk management, supplier audits and training.
IT assessments (including cybersecurity), disaster recovery and business continuity planning, and ongoing managed IT services tailored to regulated customers.
Advisory services for startups and mid-size life-science organizations covering QMS implementation, process improvements, SaaS governance, IT compliance, audits and regulatory remediation.
Ongoing managed services including audit readiness, audit support, internal audit and periodic review, and CRO/CMO vendor qualification.
Requirements gathering, software design and development, testing and implementation of cloud or on-premises systems; automation of compliance workflows using no-code platforms.
Cloud platform qualification, cloud software validation, release and change management, and validation support including IQ/OQ/PQ activities.
Support for medical device companies on regulatory compliance with Quality System Regulation (QSR, 21 CFR Part 820), design controls, risk management, supplier audits and training.
IT assessments (including cybersecurity), disaster recovery and business continuity planning, and ongoing managed IT services tailored to regulated customers.
Expertise Areas
- Quality Management Systems (QMS)
- GxP and regulatory compliance (21 CFR Part 11, Annex 11, Part 820)
- Computer systems validation and computer software assurance
- Cloud (SaaS) governance for regulated environments
Key Technologies
- No-code compliance automation platforms
- Cloud-based (SaaS) systems and cloud platform qualification
- Computer systems validation (CSV) / Computer Software Assurance (CSA)
- NIST cybersecurity frameworks
News & Updates
FDA CSA vs.
Comparison of Computer Systems Validation and Computer Software Assurance, with a free presentation available.
MTI is now using Easy-GxP, a no-code Part 11 QMS platform for creating compliance processes.
FDA CSA vs.
Comparison of Computer Systems Validation and Computer Software Assurance, with a free presentation available.
MTI is now using Easy-GxP, a no-code Part 11 QMS platform for creating compliance processes.