Medical Device Expertise

Extensive experience in providing medical device development consulting services

DSI’s medical device experts have extensive experience providing medical device development consulting following ISO 13485, FDA 21 CFR 820, and MDR guidelines. In addition, our experts can provide worldwide regulatory strategy and clinical study consulting to device design teams and manufacturers of medical device and combination device products.



Our mission is to provide guidance and value at every step of the medical device development process, from conception to classification, submission, and clinical trials through commercialization

Knowledge and Hands-on Experience in Hundreds of Successful World-Wide Registrations and Regulatory Submissions

Our breadth of experience allows us to develop comprehensive strategies to position clients for successful worldwide regulatory approvals. For each engagement, we leverage our knowledge and hands-on experience in creating product development pathways and worldwide regulatory strategies to support marketing medical devices all over the world.

Medical Device Development Strategy

  • World-wide device classification according to Intended Purpose
  • Identification of applicable recognized consensus standards and guidance documents
  • Identification of required testing
  • Identification of submission type based on classification and country
  • Identification of documentation needed for future market applications

Medical Device Regulatory Strategy

  • World-wide device classification
  • Identification of Product Codes and Global Medical Device Nomenclature (GMDN) Codes
  • Identification of potential predicates
  • Identification of items needed to support equivalence
  • Assessment of device changes

World-Wide Regulatory Application

  • Provide breakdown of process and estimated timelines for each individual country
    • USA
    • EU
    • UK
    • Canada, Brazil, Australia, Japan, China
    • Rest of World (ROW)
  • Provide classification and document requirements for individual country applications
  • Author and review market submission/application

510(K) – Medical Device Application

  • 510(K) type Identification
    • HDE Apporvals
    • Tradisional 510(k)
    • Special 510(k)
    • De Novo
    • CE Marks
  • Identification and assessment of supporting documentation for 510(k) submission
  • Completion of required FDA Forms
  • Author and review 510(K) application
  • 510(K) assembly and eCopy creation

Investigational Device Exemption (IDE) and Medical Device Clinical Study

  • Assist with Clinical Study Protocols, Case Report Forms (CRF) and Informed Consent documents
  • Identification and assessment of supporting documentation for IDE submission
  • Completion of required FDA Forms
  • Author and review IDE application preparation
  • IDE assembly and eCopy creation
  • IDE Supplements and Amendments preparation
  • Clinical Study adverse event/serious adverse event (AE/SAE) report preparation

Premarket Approval Application (PMA)

  • Identification and assessment of supporting documentation for PMA submission
  • Completion of required FDA Forms
  • Author and review premarket approval application (PMA) preparation
  • PMA assembly and eCopy creation

Post-Market Approval

  • Adverse Event Reporting
  • Warnings, Precaution, Contraindication Instructions for Use (IFU) Updates
  • Assessment of device changes for a Note to File or a New Submission