Engineering Solutions
Design Under Control
Engineering Excellence for Medical Devices & Regulated Industries
Resolvem Inc. is an engineering services company focused on transferring product design to design control and manufacturing.
We focus on details and allow our customers to focus on the big picture and their most important design improvements.
Our Capabilities
Product Development
Establishing DMR – Prototype design under QMS control.
Concept &Prototype Development (Mechanical, Electrical & Software).
- Systems Engineering
- Risk Management
- Test Protocol Development
Quality Assurance
Configuration control management.
Non-Conformance (NCR) engineering support and processing.
Complaint trend investigations.
Corrective Actions and Preventive Actions (CAPA) projects.
Non-Conformance (NCR) engineering support and processing.
Complaint trend investigations.
Corrective Actions and Preventive Actions (CAPA) projects.
Manufacturing Engineering
Supplier Acq. & Management
Design For Manufacturing (DFM) and Service (DFS).
NPI – Product Transfer from R&D to production.
Component engineering (RoHS, REACH, 2nd source)
IQ/OQ/PQ.
Process Validations.
Sustaining engineering and end-of-life replacements.
First Article Inspections (FAI).
Process Improvements.
Packaging design and validation.
Call us when…
Lacking SME
If your team has gaps in expertise, we can provide seasoned specialists to guide you through complex challenges. Our industry veterans are ready to support your needs.
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Bandwidth Constraints
When your resources are stretched thin, we can augment your team with skilled professionals. We help alleviate pressure and ensure critical deadlines are met.
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Next Gen Development
Starting on next-gen medical devices? We offer comprehensive product development capabilities, helping you innovate while maintaining compliance with industry standards.
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Missing Project Milestones
If your timelines are slipping, reach out to us. We can analyze the situation, identify bottlenecks, and implement strategies to get your project back on track.
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Facility Moves & Transfers
Relocating production facilities? We can manage the logistics to ensure a smooth transition while meeting all regulatory and quality standards.
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Change in Supply Chain
Facing supply chain disruptions? Our experts can assist with supplier management and acquisition, helping you mitigate risks and maintain continuity.
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Rapid Company Growth
Experiencing rapid growth? We can help you scale operations, providing engineering support and compliance expertise to sustain your expansion.
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Loss of Key Personnel
Losing key team members can create gaps. We can step in to bridge those gaps and maintain momentum on your projects while you seek permanent solutions.
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Regulatory Events
In the face of regulatory challenges or audits, having experienced professionals is crucial. We provide the expertise needed to navigate these situations and ensure compliance.
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Our way
Resolvem offers flexible engineering solutions through a dynamic, scalable team that integrates seamlessly with customer operations. Each project is managed by a dedicated point of contact, with services tailored to customer needs, whether on-site or remote. Resolvem emphasizes a customer-centric approach, working closely within the customer’s QMS to deliver high-quality results.
Dynamic Team
Resolvem optimizes resource management by adjusting team size according to project requirements. This approach guarantees that specialized expertise is always available, ensuring efficient execution and successful outcomes at every project stage.
Point of Contact (POC)
Each customer project is assigned a main point of contact, ensuring consistent communication and streamlined project management. This helps in building a strong client relationship and provides a single channel for all project updates and queries.
Integration with Customer Team and PLM
Resolvem integrates seamlessly with the customer’s internal team and Product Lifecycle Management (PLM) systems, fostering collaboration and enhancing project workflow. This approach ensures alignment with the customer’s processes and goals.
Flexibility (On-Site or Remote)
Services can be delivered on-site or remotely, based on customer needs and cost considerations. Resolvem adapts to the preferred working environment, offering the flexibility to match project-specific requirements.
Customer-Centric Problem-Solving
The company prioritizes understanding and addressing customer challenges. With a problem-solving mindset, Resolvem develops solutions tailored to the client’s unique needs, achiving project outcomes.
Quality Management System (QMS)
Resolvem collaborates closely with the customer’s Quality Management System, ensuring compliance with regulatory and quality standards. This helps in maintaining high standards to deliver reliable, high-quality engineering solutions.
Why choose us?
Choose Resolvem for adaptable engineering solutions, seamless integration, and reliable, tailored results.
- Multi-Disciplinary Expertise: Comprehensive solutions in mechanical, electrical, and software engineering.
- End-to-End Services: From concept to production, covering design, risk management, and process validation.
- Regulatory Compliance: Expertise in standards like RoHS, REACH, and medical device regulations.
- Customer-Centric: Flexible, scalable solutions tailored to your needs.
- Cost Efficiency: Design optimization and efficient process management to reduce costs.
- Innovation & Improvement: Focus on DFM (Design for Manufacturing), process enhancements, and sustaining engineering.
Some of our customers
Our customers praise Resolvem for seamless collaboration, tailored solutions, and consistently reliable results that drive project success.
Meet the Team
ITZHAK FANG
CEO & CTO
Results-focused executive and individual contributor, with more than 20 years of experience in research and development (R&D) and new product introduction (NPI) in medical devices and aerospace. Expertise in leading small local teams and international distributed teams.
Specialties: safety critical products, medical devices, multi-disciplinary team leadership and management, translating market needs to product requirements. Taking an idea to commercialization and product life management
DAN GONZALEZ
Sr. Director & Master Black Belt- Six Sigma,
Lean, and Design Excellence expert with more than 25 years experience internationally.
Specialty in efficient Integration of Labor, Machines, Materials, Energy & Information via Lean, 5S, Six Sigma, Design Excellence, Facility Layout, Labor Studies, Process/Supplier Qualification, Risk Management, Facility Planning, Engineering Ethics, & Finance.
YARON DEGANY
Project and Operations Director
with 20 years of international experience in the Automotive, Aerospace, and Medical sectors.
Expertise in root cause analysis and CAD modeling, alignment of engineering initiatives with corporate goals, driving innovation, and operational excellence.
Specialty in guiding complex engineering projects from R&D to commercialization through technical rigor, regulatory compliance, and integration of quality standards while leading cross-functional teams.
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Contact us
Let’s work together
Get in touch today and receive a complimentary consultation.
Phone
- +1 (949) 887-6727