MEDICAL DEVICE ENGINEERING
Our crew brings extensive medical device engineering experience to a variety of challenging medical device and combination product development efforts. We provide systems engineering and technical leadership for our customers in the following areas, and can team up with our partners to offer true end-to-end product development under a Quality System certified to ISO 13485:2016.
Safety Risk Management : Cybersecurity and Cybersecurity Risk Management : Compliance Program Leadership (e.g., IEC 60601-1, IEC 62304, IEC 62366-1) : Requirements Development (User and Stakeholder Needs, System Requirements, Software Requirements) : Verification : Validation : Human Factors
MEDICAL DEVICE REGULATORY
Our regulatory team leverages our cross-cutting medical device and combination product experience, several RAPS Regulatory Affairs Certifications (RAC, RAC-US), and a multitude of direct interactions with FDA and Notified Bodies to bring you practical approaches to dealing with medical device and combination product regulations. Our EU and FDA regulatory consulting teams work well in the “grey” area of regulation, standards, and guidance. Our typical regulatory engagements include:
Q-Submissions / Pre-Submissions : 510(k) Preparation and 510(k) Submissions : eSTAR : De Novo Submissions : 513(g) Requests : Regulatory Strategies : Remediation : Technical File Construction : Design History File (DHF) Development and Maintenance : Device Master Record (DMR) Management
MEDICAL DEVICE QUALITY
Our decades of experience in contract R&D and medical device consulting has provided us with the unique opportunity to implement right-sized medical device quality systems using a risk-based approach. One size quality system does not fit all! We pride ourselves on quality services that ensure compliance with standards, regulations, and guidance in a practical, easy-to-follow manner. We have developed our own 21 CFR Part 11 compliant electronic document control system, “Astro,” as an affordable and simple solution for small- to medium-sized medical device companies (including ourselves!). Our quality services include:
Medical Device Quality System Development (21 CFR 820, ISO 13485) : Quality System Management : Quality System Certification : Document Control : Electronic Document Management Systems (21 CFR Part 11 Compliant) : Audit and Inspection Support : Quality System Training
PROJECT MANAGEMENT AND
PROGRAM MANAGEMENT
Our project and program managers bring decades of medical device and combination product experience to plan and execute complex product development efforts. Our strength lies in the combination of our management expertise with our extensive experience in technical product development, regulations, guidances, and consensus standards. Our team excels in driving communication within an organization, with multiple development partners, and with third parties (e.g., IEC 60601-1 and biocompatibility testing) to get products on the market efficiently. Our team helps you plan a comprehensive program budget and schedule, minimizing surprises and unforeseen hurdles. Our services include:
Schedule : Budget : Program Risk Management : Earned Value / EVMS : KPI Development and Tracking : Due Diligence Assessments : Acquisition Support
LABORATORY DEVELOPED TESTS (LDT)
Our experienced team guides laboratories through the FDA’s new LDT regulation enforcement requirements, combining our medical device expertise with practical laboratory operations knowledge. We understand the unique challenges labs face in transitioning from CLIA oversight to FDA regulation, and we help implement right-sized solutions that maintain efficiency. Our LDT consulting services include:
Quality Management System Development : Implementation Support : Medical Device Reporting Systems : FDA Registration Guidance : Test Documentation and Validation : Risk Management Planning : Staff Training Programs : Electronic Records Compliance : Pre-Market Review Support : Change Management