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ISO 9001:2015 Certified Company

End to End Medical Device Competencies

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Empowering Innovation, Ensuring Compliance

We are committed to support your journey from concept to market with unparalleled expertise and a commitment to excellence.

Embark on your medical device development journey with confidence. Our end-to-end competencies can turn your vision into a reality. Together, let's shape the future of healthcare, Navigate the complex landscape of regulatory requirements with confidence, ensuring your devices meet FDA and international standards.
We embrace innovation and incorporate the latest technologies to keep your medical devices at the forefront of the industry.
  • CE Technical file
  • 510(k), PMA, De-Novo, IDE, HDE, Pre-Submission applications
  • Global UDI compliance
  • Country specific labeling compliance
  • Current technical file/dossier compilation
  • Technical guidance on implementation of IMDRF guidance along with regional guidance’s
  • Labelling gap analysis
  • SOP writing
  • Risk management (ISO 14971)
  • Single point of contact in the country for liaison with Health Authorities (HA) for submissions, queries and feedback.
  • Independent Marketing Authorization Holder (MAH) services
  • Flexibility to change the distributors
  • Support for the change of legal representative
  • Dedicated PRRC, UKRP, Swiss AR, and EAR in-house experts
  • Review of the QMS documentation and support for Audit compliance, and design of remediation plans
  • Support for MDSAP/ ISO 13485 audits and documentation
  • Support for country specific QMS requirements compliance and certification
  • Clinical evaluation reports (MEDDEV 2.7.1)
  • Clinical investigation protocols and reports
  • Development of user manuals/quick start guides
  • Product classification and gap analysis of the technical documentation
  • Compilation and submission of technical files to agency
  • Optimization of the data for submission in multiple markets
  • and support for conformance to local regulatory requirements
  • Support for import permit/license
  • liaison with MOH/agency for approvals
  • Interaction in local language with agency/MOH for ease of communication
  • Local presence availability for in-person meetings with MOH, feedback on submissions, queries
  • Support for labelling and technical file translations

Expertise You Can Trust

With years of experience in the medical device industry, our team brings a wealth of knowledge and a proven track record of successful projects.

End-to-End Support

From ideation to market launch, we provide comprehensive support, simplifying the development process for our clients.

Compliance Assurance

Stay ahead of regulatory challenges with our in-depth understanding of FDA and international standards, ensuring your product's timely market entry.

Global Pharmacovigilance Regulatory Services partner

Business Development Services
Medical marketing services
US Agent
Quality Assurance
Clinical Data Management
Medical Writing Services
Clinical Trails
Regulatory Consulting Services
Pharma Regulatory Consulting services
Pharmacovigilance Services
Medical Devices Expertise
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