FDA regulatory support, from first submission to full lifecycle management.

Every engagement is defined by the technology, the regulatory stage, and what the program actually needs. We work across the full device development lifecycle, from early pathway strategy through post-market compliance, and across all major device categories, including implantables, IVDs, SaMD, and combination products. Whether the need is targeted and specific or end-to-end, the depth of engagement is the same.

01

Regulatory Strategy & Pathway

From first classification decision to submission-ready plan

  • FDA pathway strategy and submission planning
  • Device classification, product code assessment, and 510(k) exemption analysis
  • Combination product determination and RFD support
  • Applicable consensus standards identification and Declaration of Conformity
  • Predicate search, intended use alignment, and substantial equivalence narrative
  • Breakthrough Device Designation: request preparation and FDA engagement
  • 513(g): Request for Classification Information
02

FDA Premarket Submissions

Full preparation and support for every premarket pathway

  • 510(k): Traditional, Abbreviated, and Special
  • PMA: Premarket Approval Application and supplements
  • De Novo: Classification request preparation
  • Q-Sub / Pre-Sub: written feedback and meeting requests
  • IDE: Investigational Device Exemption
  • Change assessment memos: determining whether a modification triggers a new submission
03

Biocompatibility & Materials Evaluation

Risk-based biological safety grounded in materials science

  • ISO 10993 strategy and biological evaluation planning
  • Biological evaluation plans (BEP) and reports (BER)
  • Chemical characterization: systematic identification and quantification of chemical substances released from device materials, including extractables and leachables
  • Toxicological risk assessment and materials justification
  • CRO protocol scientific review and study design alignment
  • Report adequacy review before submission
04

Testing Strategy & Evidence Planning

Designing the evidence before committing the budget

  • Testing matrix recommendation and gap analysis
  • Performance test design aligned with FDA-recognized standards
  • Sterilization, shelf-life, packaging, and usability testing strategy
  • CRO engagement support and report adequacy review
  • Labeling review: FDA requirements, UDI compliance (21 CFR Part 830), and IFU review
  • Applicable consensus standards mapping and Declaration of Conformity
05

Quality System & Compliance

Regulatory obligations beyond the submission

  • FDA QSR (21 CFR Part 820) / ISO 13485 gap assessment
  • Design controls review and documentation support
  • Establishment registration and device listing (21 CFR Part 807)
  • UDI system compliance review
  • Post-market surveillance plan development
  • Post-approval study (PAS) design for PMA holders
  • MDR (Medical Device Reporting) advisory: reportability determinations and 21 CFR Part 803 obligations
06

FDA Enforcement Response & Remediation

Strategic and scientific support when FDA has questions

  • FDA deficiency and Additional Information (AI) response strategy
  • Warning Letter response: root cause analysis, CAPA, and response drafting
  • FDA Form 483 response: observation-by-observation strategy
  • Recall strategy, classification planning, and FDA coordination
  • Field Safety Corrective Action (FSCA) planning and documentation
  • Consent Decree advisory and Import Alert response strategy
  • Lifecycle management: modifications, line extensions, and new indications