Perpetual
Regulatory Compliance,
Simplified for Success

Built for Every Medical Device and Software,
Designed for Every Regulation .

Mapped Workflows for Each Clause of QMS Standards and Regulations

QMS Standards:

  • ISO 13485:2016
  • EN ISO 13485:2016
  • IEC 62304
  • IEC 62366
  • ISO 14971:2019; EN ISO 14971:2019
  • US FDA 21 CFR 820
  • Fifth Schedule of Indian MDR 2017
  • MDSAP

Regulations:

  • I-MDR 2017
  • EU MDR 2017/745
  • US FDA - 510(k) and Premarket submission

Mapped Workflows for Each Clause of QMS Standards and Regulations

QMS Standards:

  • ISO 13485:2016
  • EN ISO 13485:2016
  • IEC 62304
  • IEC 62366
  • ISO 14971:2019; EN ISO 14971:2019
  • US FDA 21 CFR 820
  • Fifth Schedule of Indian MDR 2017
  • MDSAP

Regulations:

  • I-MDR 2017
  • EU MDR 2017/745
  • US FDA - 510(k) and Premarket submission

Meet Your Cloud-based eQMS Guide

MeDStrat360, a modular, cloud-based intelligent eQMS platform that simplifies compliance processes, integrates workflows, and allows companies to focus on innovation, reduce time-to-market and costs.

With MedStrat360, companies can:

  • Automation of all QMS processes including documentation, CAPA, audits, complaint handling, regulatory submissions, and more.
  • Seamlessly adapt to global regulations like I-MDR, USFDA, EU-MDR, and more.
  • Ensure traceability and accountability across the lifecycle of a medical device.
  • Stay ahead with real-time system-wide updates in line with regulatory changes, enabling perpetual compliance.
When scaling across international markets, MeDStrat360 acts as your compliance companion, ensuring every step aligns with the respective QMS and Regulatory requirements.

The MeDStrat Innovations Difference

Although pre-market, MeDStrat Innovations is designed with measurable efficiency and compliance gains
in mind. These assumptions are based on industry benchmarks and the capabilities of our platform.

Reduction
0 %
In rework
Decrease
0 %
In audit preparation time enabled by perpetual-compliance workflows
Faster Market Entry
0 %

Due to streamlined regulatory submission processes.

Improvement
Up to 0 %
Across all QMS functions—out of the box
Time Savings
0 %
Reduce Cost of Quality by Upto 40% with consistent, audit-ready workflows that minimize rework and manual effort.

Build Your Perfect Compliance Framework

The foundation of MedStrat360 platform is its robust set of standard modules, designed to streamline quality management and regulatory compliance. These modules handle the essential processes every medical device company requires to ensure operational excellence and maintain regulatory alignment.
  • Document Management: Centralize, organize, and control documents with version tracking and approval workflows.
  • CAPA (Corrective and Preventive Actions): Proactively manage quality issues with actionable CAPA workflows.
  • Audit Management: Simplify internal and external audits with automated workflows and reporting.
  • Competency and Training: Track employee competence and ensure continuous skill development.
  • Complaint Management: Streamline the complaint management process to track, manage, and resolve issues efficiently.
  • Management Review: Facilitate top-level review processes with actionable insights.
  • Infrastructure Management: Optimize and oversee infrastructure to meet QMS and Regulatory requirements seamlessly.
  • Data Analysis: Gain actionable insights through advanced analytics for decision-making.
  • Control of Monitoring and Measurement Equipment: Ensure accurate and compliant equipment calibration and maintenance.
For companies with unique operational needs, MeDStrat offers role-based modules that expand functionality and tailor compliance strategies. These modules enable scalability and cater to specialized workflows, making the platform adaptable for diverse companies.
  • Design and Development: Manage design processes, iterations, and approvals with traceability.
  • Risk Management: Identify and mitigate potential risks across product lifecycles.
  • Supplier and Outsourcing Management: Ensure supplier quality and manage outsourcing partnerships effectively.
  • Medical Device Vigilance: Monitor, report, and follow up on real-world device performance with built-in workflows that support post-market surveillance and clinical follow-up compliance.
  • Marketing and Sales: Track customer insights, manage promotional material approvals, and maintain compliance across regions with structured workflows that align with regulatory expectations for market communication.
  • Manufacturing: Ensure product consistency and regulatory compliance by linking production processes with quality controls, traceability, and deviation management in one centralized system.
  • Regulatory Submissions: Meet compliance requirements across multiple regions with efficient, system-driven regulatory submission processes.

Guiding Every Device to Regulatory Success

Active Devices

Pacemakers, infusion pumps, X-ray machines, and more

Non-Active Devices

Surgical instruments, bandages, orthopaedic implants, and more.

In Vitro Diagnostic (IVD) Devices

Blood glucose monitors, COVID-19 test kits, pregnancy test kits, and more.

Software as a Medical Device (SaMD)

Mobile apps for diagnosing conditions, software for managing chronic diseases, AI-based radiology tools, and more.

Contact Us

Meet The Minds Behind MedStrat360

Sriram

CEO & Co-Founder

A compliance expert with over 40 years of experience in guiding medical device companies. Sriram’s strategic leadership ensures that MeDStrat Innovations remains at the forefront of regulatory advancements.

Kannan

CFO & Co-Founder

A seasoned entrepreneur with a rich background in finance and operations. Kannan brings business acumen and financial expertise to drive MeDStrat Innovation’s growth.

Ragav Kannan

Head of Marketing

A marketing strategist with global Operations experience at Apple, Caterpillar, and Lam Research, Ragav specializes in aligning market needs with scalable, compliance-driven solutions.

Contact Us

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