Want the right product the first time? Systems Engineering assures that the users' needs and the product's intended use are met – the first time through development.
Systems Engineering is an engineering discipline whose responsibility is creating and executing an interdisciplinary process to ensure that the customers' and other stakeholders' needs are satisfied in a high quality, trustworthy, cost efficient and schedule compliant manner throughout a system's entire life cycle. Founded by Systems Engineers, CMD MedTech is well equipped to lead or provide systems engineering assistance to companies throughout the medical device development continuum... whether it be feasibility, design and development, or sustaining marketed products.
- System Design and Architecture, including Software Design and Architecture, and UML and SysML Modeling Methods
- Requirements Development: Stakeholder/User Needs, System, Software and Subsystem
- Assessment and Practical Implementation of Regulations, Standards, and Guidance.
- Safety Risk Management
- Verification Planning and Execution
- Validation Planning and Execution
Want the product delivered on-time and within budget? Project Management manages the project risks to assure product delivery within stated schedule and budget.
Project management is the application of knowledge, skills, tools, and techniques to project activities to meet the project requirements (adopted from PMI). Project Management is about managing risks and customer expectations. Solving complex challenges are integral in product development, and issues will and do arise during the course of development. An organization is defined by how it addresses the issues and moves forward. As a customer of CMD MedTech our promise to you is no surprises, you may hear unfavorable news but you will not be surprised.
- Technical Project Management
- Task Leadership
- Assistance with Setting up Project Management and Key Metrics (Project Planning – Budget and Schedule, Earned Value, Key Performance Indicators)
Looking for a practical, business-balanced approach to quality and regulatory? We use our breadth and depth of experience to tailor solutions that balance the needs of regulation with the needs of the business.
We pride ourselves on our practical approach to quality and regulatory. We differentiate ourselves by our ability to bridge the divide between quality/regulatory and engineering, particularly software-centric medical devices. CMD's staff each have a minimum of 15 years of experience in medical and in vitro diagnostic devices. A majority of CMD's staff have the RAPS Regulatory Affairs Certification (RAC)-- requiring in-depth regulatory knowledge and continuing education. We approach regulatory and quality problems using the principles of systems engineering; we help you find the "sweet spot" between design burden, cost, timeline, and regulatory risk.
- DHF Remediation of Complex Electromechanical Medical Devices
- Regulatory Strategies
- 513(g) Requests, Q-Submission (Pre-Submission) Requests, and Meeting Support
- Medical Device Regulation (MDR) / In Vitro Diagnostic Regulations (IVDR) Transition Leadership
- 510(k) Preparation and Submission
- Technical File Development
- Computer System Validation / 21 CFR Part 11 Compliance
- Contract Quality Manager and Quality System Management
- Quality Management System (QMS) Development and ISO 13485 Certification Support
- Quality System Audits, 3rd Party Audits, and Audit Preparation
- Regulated Software Process Development, including Agile Methodologies
Want a product design that meets requirements? Design & Development Engineering assures that the product meets the requirements you defined.
Design & Development Engineering is the application of the engineering disciplines to achieve the system requirements through the design. CMD MedTech has both the capability and expertise in the following areas of Software Engineering and Electrical Engineering (broader expertise can be fulfilled through our partners - e.g. Mechanical Engineering).
- Software Engineering
- Embedded, Mobile Applications, Desktop Applications
- Design & Development
- Software Development Planning & Process including AGILE Development
- Compliance to AAMI TIR45 and EN/IEC 62304
- Electrical Engineering
- COTS Integration
- Custom Electronic Circuit Design