A leading manufacturer of minimally invasive medical devices and electronic hardware. Through CFR 21 Part 820.30 QSR, ISO-13485, 93/42/EEC-Medical Device Regulation including other International Regulatory Bodies requirements, we help our clients with product realization; from concept to Design Input, Design Output, Design Verification/Validation, Clinical Studies, Product Transfer, Product Launch and Regulatory Readiness.
1. To strive with no reserve for the greatest possible reliability and quality in all our services.
2. To streamline product manufacturability and enhance process development.
3. To continue to research technical innovative advancement that will help our clients improve productivity – reduce cost, increase expediency and time to market .
4. To align with all regulatory requirements, operate within all local and international standards and to remain in compliance with our internal quality standards.
5. Self-assessment of our internal manufacturing practices and business conducts through recognized self-auditing organizations.
6. To recognize the personal worth of our employees by providing an employment framework that allows personal development and advancement opportunity.
Through automation design, manufacturing, supply, and environment controls we help our clients minimize production inefficiencies.
We have broad experience with manufacturing of indoor and outdoor enclosures for communications networks, computing, medical
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Do you need help with validation? We offer validation services in equipment