At DSI, we specialize in providing comprehensive medical device consulting services, ensuring that companies successfully navigate the complex global regulatory landscape. Our experts bring extensive experience in ISO 13485, FDA 21 CFR 820, and MDR compliance, delivering tailored solutions for medical devices, combination products, and diagnostics from early-stage development through commercialization.
We help clients overcome regulatory and technical challenges by offering strategic guidance and hands-on support throughout the device lifecycle. Whether you need assistance with classification, regulatory submissions, clinical studies, or post-market compliance, DSI is your trusted partner in achieving market approval efficiently and effectively.
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
End-to-End Medical Device Consulting Services
Our expertise covers all aspects of medical device development, regulatory strategy, and compliance, helping clients streamline their pathway to market.
Medical Device Development Strategy
- Global Classification & Regulatory Pathway Identification: We determine the appropriate device classification based on intended purpose, risk level, and regulatory jurisdiction.
- Standards & Guidance Compliance: We assist in identifying and implementing recognized consensus standards (ISO, IEC) and FDA/EU regulatory guidance.
- Testing & Documentation Requirements: We ensure that biocompatibility, electrical safety, and performance testing meet regulatory expectations.
- Regulatory Submission Planning: We develop submission strategies based on classification, regulatory pathway, and country-specific requirements.
Regulatory Strategy & Global Compliance
- Worldwide Device Classification & Registration: We support clients in the U.S., EU, UK, Canada, Brazil, Australia, Japan, China, and ROW markets.
- Product Codes & GMDN Identification: We help classify devices under FDA Product Codes, Global Medical Device Nomenclature (GMDN), and EU MDR UDI regulations.
- Predicate Device Identification & Substantial Equivalence Assessment: We conduct comparative analyses to determine the best 510(k) or CE mark pathway.
- Regulatory Impact Assessments for Device Modifications: We evaluate device changes to determine if they require a new submission, supplement, or simple documentation update.
Worldwide Regulatory Applications & Submission Services
- Regulatory Pathway Mapping & Timelines: We provide a step-by-step roadmap for regulatory approvals across multiple global markets.
- Comprehensive Regulatory Submission Support: We author, review, and submit regulatory applications tailored to specific country requirements.
- U.S. FDA Submissions:
- 510(k) Applications: Assistance with Traditional, Special, and Abbreviated 510(k) filings.
- De Novo Submissions: Support for novel medical devices without existing predicate devices.
- Humanitarian Device Exemptions (HDE): Regulatory support for devices targeting rare diseases.
- Investigational Device Exemption (IDE): Clinical study design, protocol development, and FDA submission support.
- Premarket Approval (PMA): Complete PMA preparation, filing, and post-approval compliance support.
- EU MDR & CE Marking Submissions:
- Notified Body Interaction & Technical Documentation Review.
- Clinical Evaluation Reports (CER) & Post-Market Surveillance (PMS).
- UDI & GSPR Compliance.
- International Market Access & Regulatory Filings:
- TGA (Australia), ANVISA (Brazil), NMPA (China), PMDA (Japan), Health Canada.
- Country-specific dossier preparation and submission.
Clinical Study & Investigational Device Support
Our team provides regulatory and operational support for medical device clinical trials, ensuring compliance with GCP and regulatory requirements.
Clinical Study Consulting & IDE Submission
- Clinical Trial Protocol Development & Regulatory Compliance: Support for study design, endpoints, and patient recruitment strategies.
- IDE Submissions & FDA Approvals: Assistance with pre-IDE meetings, application preparation, and amendments.
- Case Report Form (CRF) & Informed Consent Document Development.
- Clinical Study Adverse Event & Serious Adverse Event (AE/SAE) Reporting.
Post-Market Surveillance & Compliance
Ensuring continued compliance and safety post-market is critical for medical device manufacturers. DSI provides comprehensive post-market support for regulatory compliance and risk management.
Post-Approval & Compliance Services
- Adverse Event Reporting & Safety Monitoring: Support for FDA MDR, EU Vigilance, and global post-market reporting.
- Device Labeling, IFU Updates & Risk Mitigation Strategies.
- Evaluation of Device Modifications & Regulatory Impact Assessments.
- Quality System Audits & Gap Assessments: Ensuring compliance with ISO 13485, FDA QSR, and EU MDR requirements.
- Regulatory Inspection Readiness & CAPA Implementation.
Why Choose DSI for Medical Device Consulting?
Your Partner in Regulatory & Product Development Success
Industry-Leading Expertise: Our team of 60+ SMEs brings extensive experience in medical device regulatory strategy, development, and compliance.
Seamless Execution: We provide both high-level strategic guidance and hands-on execution, ensuring efficient approvals.
Global Market Access: Our regulatory expertise spans the FDA, EMA, TGA, NMPA, PMDA, and other health authorities.
End-to-End Solutions: From early development through post-market compliance, we cover the entire device lifecycle.
Commitment to Quality & Compliance: We prioritize regulatory accuracy, client collaboration, and project success.
Partner with DSI Today
Ensure regulatory success and market access for your medical device or combination product with DSI’s expert consulting services.
Contact us today to discuss how we can tailor solutions to meet your regulatory and development needs.
