Medical Systems Consult

Medical Devices, 26 Orch St, Dracut, Massachusetts, 01826, United States, 1-10 Employees

Phone Number: +19*********

Who is MEDICAL SYSTEMS CONSULT

Medical Systems Consult is a systems engineering and product development consulting company specializing in electromechanical medical devices, IVD automation software, and digital health ...

Get Full Access

Headquarters: 26 Orch St, Dracut, Massachusetts, 01826, United States
Date Founded: 2016
Employees: 1-10
Revenue: Under $1 Million
Active Tech Stack: See technologies

Industry: Medical Devices

Does something look wrong? Fix it. | View contact records from MEDICAL SYSTEMS CONSULT

Medical Systems Consult Org Chart and Mapping

Employees

Louiza Tawadros

Human Resources Manager

Email
Phone

See Full Org Chart

View Email Formats for Medical Systems Consult

You are signed out

Join Now

Free credits every month

Frequently Asked Questions Regarding Medical Systems Consult

Answer: Medical Systems Consult's headquarters are located at 26 Orch St, Dracut, Massachusetts, 01826, United States

Answer: Medical Systems Consult is a systems engineering and product development consulting company specializing in electromechanical medical devices, IVD automation software, and digital health solutions. At Medical Systems Consult, our working model is based on a systems thinking approach with emphasis on collaborations between cross-functional business stakeholders and subject matter experts, and driven by international state of the art standards and best practices - the results are High Quality, Effective & Innovative Solutions, On-Time and On-Budget. Medical Systems Consult can partner with you to bridge any gaps in technical staffing, multi-disciplinary product development and testing, and regulatory compliance consulting. We have established a rich network of subject matter experts & associates that have a unique skill set, from product design, complex system engineering, human factors and mechanical engineering through full-stack software and interconnectivity for IOT to market access and total product life cycle management. Our associates network includes experts in combination products, connected health solutions, clinical validation, usability/human factors, former regulatory agency auditors, application specific post-market, expert review panels, safety conformity assessments and certifications, and many other fields, to help get your products to market quicker. Our specialties include: - Software Development Life Cycles for Safety-Critical Class II and III Medical Devices, meeting IEC 62304 and ISO 14971 requirements, aligning SOPs and generating complete DHF artifacts for compliance coverage. - Risk Management per ISO14971, incorporating software validation and traceability, and aligning with current FDA guidance on current topics such as cybersecurity risk management, human factors aspects, and Software as a Medical Device (SaMD) design principles. - Quality Management Systems meeting ISO 1385, 21 CFR 820 & 21 CFR 803, and Part 11.