Extensive experience in providing medical device development consulting services
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 Approvals
- Traditional 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
DSI's RECENT MEDICAL DEVICE POSTS
February 24, 2023
Global healthcare systems require medical devices that are safe and effective in the diagnosis, treatment and prevention of diseases, and physicians rely on a wide range of medical devices to help identify and treat said ailments. However, for medical devices to be considered both safe to use and effective for […]
October 14, 2022
An Investigational Device Exemption (IDE) is an application submitted to obtain the FDA's approval for use of a novel medical device in a clinical study. This allows for the collection of safety and effectiveness data in order to support full market approval. IDE applications support several types of studies: to […]
August 8, 2022
You've likely heard the phrase “time is money.” No other statement could be more accurate for the medical device industry. Each day your company is not approved to market your device is not only a day of lost revenue, but a day patients don’t get to benefit from the value […]
June 7, 2022
Medical devices have been saving lives for decades. And medical devices are quickly changing as new technology such as 3D printing, software, hardware and algorithms are being incorporated into device designs. Medical devices are not simply band aids and thermometers any longer. They are sophisticated designs that help people with a myriad of problems and in many cases, they prolong and save lives.
