Loading...

Devan your MedTech Solutions

Your trusted partner in MedTech Regulatory Processes

Get Started

About Us

Devan Medtech Solutions is the professional end-to-end solution for your medical devices and software. Regulatory processes become easier and faster. With 10+ years of experience and expertise of company founder Amit Guruprasad, we can help you launch your products in the market quickly and safely. The focus of our services is to guide you through complex processes, reduce compliance risks and provide cost-effective solutions.

Read More

Our Expertise: The Key to Your Success

Devan MedTech Solutions stands on three major pillars: Benefits, Authority, and Partnerships.

Benefits

  • Expert Guidance in Regulatory Landscape
  • Accelerated Development and Market Entry
  • Reduced Risk of Compliance and Costly Delays
  • Personalized Support from Experts

Authority

With Amit Guruprasad’s 10+ years of MedTech experience and successful FDA submissions, Devan MedTech Solutions is trusted in the industry.

  • In-Depth Knowledge of Regulatory Requirements
  • Proven Track Record in FDA Submissions

Partnerships

Through collaborations with industry organizations, Devan MedTech Solutions actively participates in the MedTech ecosystem, ensuring your product's success.

Our Customers

Our services are designed for diverse groups given specific niches:

Medical Device Manufacturers

SaMD Developers

Healthcare Innovators

Regulatory Affairs Professionals

Quality Assurance Specialists

Our Expertise: The Key to Your Success

Devan MedTech Solutions is based on ten major pillars: Benefits, Authority, and Partnerships.

Our Services

Regulatory Consulting

FDA Submissions (510(k), PMA, De Novo)

We guide you in preparing required documents and ensuring compliance practices for successful FDA submissions.

Quality Systems Implementation (21 CFR 820, ISO 13485)

We help you implement essential quality systems, ensuring quality and safety standards are met consistently.

Quality Assurance

Audits and Compliance

Our team audits your products and processes, ensuring they meet industry standards and regulatory requirements.

Risk Management

We work with you to identify and mitigate compliance-related risks, keeping your business and customers safe.

Risk Analysis

Hazard Analysis and Mitigation

We help identify potential hazards in advance and create strategies to resolve them, keeping your product safe.

Usability and Human Factors Engineering

Using human factors engineering techniques, we ensure your product is safe and user-friendly.

Thought Leadership: Your Knowledge Partner

In our Insights section, you will find valuable information such as:

  • Regulatory Updates and News
  • Industry Trends and Analysis
  • Best Practices for MedTech Development and Compliance

Our blog, articles, and podcasts provide deep insight into MedTech and regulatory topics, helping you make informed decisions.

Our Latest Updates

Stay updated with our webinars, workshops, and events. You’ll also find summaries of our latest blog posts and podcasts.

Contact Us

Get in Touch with Our Certified Consultants

Ready to take your MedTech product to market with compliance and expertise? Contact us for a free consultation and see how our team can support your regulatory and compliance needs every step of the way.

Make a Call Get Appointment

Our Clients Say!

Our clients' success stories reflect the dedication and expertise we bring to every project. Hear from those who trust us with their MedTech needs.