Services & Capabilities

Product Development

Resolvem provides mechanical, electrical, software, and systems engineering from concept through prototype, ensuring designs are robust, usable, and ready for controlled development.

Documentation, DMR, & Compliance

Resolvem creates audit-ready DMRs, risk management files, test protocols, traceability and regulatory compliant documentation that meets QMS and compliance requirements with precision.

Engineering

Resolvem manages the full transition from R&D to manufacturing, including Design for Manufacturing and Service, supplier onboarding, process validation, and readiness for production and clinical builds.

Manufacturing & Sustaining Engineering

Resolvem supports production with process improvements, component engineering, EOL replacements, non-conformance investigations, and continuous DFS and reliability enhancements.

Change Order Management & ECO Services

Resolvem executes high-volume ECOs, redlines, PLM updates, configuration control, and documentation remediation to eliminate bottlenecks and maintain regulatory clarity.

Workflow & Human Factors Engineering

Resolvem maps workflows, analyze user tasks, and apply usability engineering to ensure devices perform safely and effectively across ICU, OR, ASC, and clinic environments.

Industrial & Graphic Design

Resolvem delivers visually compelling product designs, UI/UX, labeling, packaging, and CAD visualizations that align aesthetics with usability and manufacturing requirements.

EXPERIENCE

• Industry Veterans: Engineers, compliance specialists, and project leaders from Fortune 500 medical device companies and specialized firms
• Deep Domain Knowledge: 20+ years across product development, manufacturing, quality, regulatory, and change management
• Proven Track Record: Over 800 drawings and component specification updates in more than 200 hundred ECOs. Rerouted after addressing any feedback from reviewers within <24 hours.

A2D (ATTENTION TO DETAIL)

• Single Point of Accountability: Dedicated onsite POC for every customer
• Quality-First Mindset: Every document, every ECO, every approval chain matters
• Compliance-Native: QMS integration, regulatory-aware approach, audit-ready delivery
• Engineering excellence: Our engineers check for stack up tolerance and any interference, our AI checks for template adherence and missing information

SPEED & SCALE

• Global 20-Hour Operations: With Radix Engineering partnership in Israel, your project never loses momentum—around-the-clock execution
• Flexible Resource Scaling: Peak demand? Launch event? Acquisition integration? Resolvem scales up immediately without disrupting your core team
• Proven Execution: Aggressive timelines met or exceeded, without cutting corners
• AI and automation: Our automation programmers are building tools to improve our engineers efficiency

CUSTOMER-CENTRIC PARTNERSHIPS

• True Integration: Resolvem doesn't just add hands—we integrate into your processes, QMS, and PLM systems
• Proactive Communication: Stakeholder alignment, milestone tracking, customized dashboards
• Cost Efficiency: Leverage offshore expertise to maximize value without breaking budgets

Resource & Bandwidth Constraints

• Lacking Subject-Matter Expertise - Need specialists in systems engineering, manufacturing, compliance, or technical documentation?
• Constrained by Internal Bandwidth - Your core team is stretched thin and project timelines are slipping?
• Bridging Key Personnel Gaps - Lost critical team members or need to augment capabilities quickly?
• Prioritizing Next-Gen Development - Current product demands are pulling resources away from innovation?

Project Timeline & Execution Pressure

• Missing Project Milestones - Deadlines at risk due to documentation backlogs or engineering bottlenecks?
• Experiencing Rapid Company Growth - Scaling faster than your team can handle and need immediate support?
• Managing Facility Transfers - Product or manufacturing moves require documentation updates and validation?

Compliance & Operational Challenges

• Navigating Regulatory Events - FDA observations, audit findings, or compliance gaps that need immediate remediation?
• Facing Supply Chain Changes - Supplier transitions, component obsolescence, or second sourcing requiring documentation and validation updates?