Our Services

Product Development Strategy & Design Control Alignment

• Early-stage product development planning grounded in engineering rigor

• Translation of user needs and clinical inputs into clear, traceable design requirements

• Integrated risk management frameworks following ISO 14971

• Design control pathway mapping (inputs, outputs, verification, validation, DHF structure)

• Technical documentation strategy to support concept-to-clearance alignment

• Patient-specific design and manufacturing workflow optimization

Regulatory Strategy & Pathway Planning

• Regulatory pathway analysis grounded in long-term development and commercialization strategy

• Predicate device evaluation and evidence strategy for 510(k) submissions

• Regulatory readiness assessments for Class I–III devices including  patient-matched and devices manufactured using additive manufacturing

• Pre-submission (Q-Sub) planning and FDA meeting strategy

• Support for FDA interactions across CDE, Compassionate Use, HDE, and IDE pathways

• Custom Device Exemption (520(b)) strategy and compliance alignment

Technical, Engineering, & Advanced Manufacturing Guidance

• Design for manufacturability (DFM) reviews for additive, hybrid, and conventional manufacturing methods

• Material, process, and engineering strategy guidance tailored to implantable and patient-specific devices

• Feasibility assessments for patient-specific implants, AM components, and complex geometries

• Verification and validation strategy development informed by mechanical, functional, and usability requirements

• Engineering documentation aligned with regulatory expectations and quality system requirements

• CAD/CAM workflow refinement and modeling guidance that supports efficient, compliant development of patient-matched and additively manufactured devices.

Quality & Compliance Support

• Design history file (DHF) development, organization, and remediation

• Quality system strategy tailored for early-stage companies

• Process documentation supporting FDA readiness and inspection expectations

• Integration of design, regulatory, and quality frameworks to support scalable growth

• Gap analysis and corrective action planning across design controls and technical files

Submission Development & Technical Documentation Support

• Submission document development for PMA, 510(k), IDE, HDE, Q-Sub, and custom device pathways

• Technical report authoring, including testing protocols, rationales, and summaries

• Engineering documentation for additive and hybrid manufacturing processes

• Gap assessments and remediation planning for incomplete or non-compliant documentation

• Evidence package alignment across engineering testing, risk management files, and regulatory expectations

Clinical, Surgeon, & User Collaboration

• Integration of surgeon and clinical stakeholder feedback into structured VOC inputs

• Translation of clinical needs into clear engineering specifications and design requirements

• Collaborative surgeon engagement throughout iterative design reviews

• Alignment of clinical workflows with technical, quality, and regulatory pathways