IMEQ offers Quality & Compliance as a Service, providing expert support to medical device companies aiming to meet rigorous global regulatory standards. This service is designed to streamline compliance with ISO 13485, MDR (EU), FDA (21 CFR Part 820), and other international quality frameworks. By leveraging IMEQs' extensive experience in medical manufacturing and regulatory affairs, clients gain access to tailored guidance on documentation, audits, technical files, and risk management systems—all while reducing internal burden and accelerating time to market.
Whether a company is launching a new device, scaling production, or navigating complex regulatory updates, IMEQs' Quality & Compliance service ensures all quality systems are effectively implemented and maintained. The service includes ongoing consultation, gap analysis, CAPA (Corrective and Preventive Actions) planning, and support during inspections, helping organizations not only meet but sustain compliance. IMEQs positions itself as a strategic partner, enabling clients to focus on innovation and growth while ensuring safety, efficacy, and regulatory confidence.
Quality & Compliance Expertise
Choosing IMEQs for Quality & Compliance means partnering with experts who combine deep regulatory knowledge with real-world manufacturing experience. We deliver tailored, audit-ready solutions that meet ISO 13485, MDR, and FDA standards—helping you avoid delays, reduce risk, and bring products to market with confidence.
Regulatory Alignment
IMEQ ensures your systems meet global standards like ISO 13485, MDR (EU), and FDA 21 CFR Part 820.
Audit Readiness
We prepare and maintain documentation, technical files, and CAPA systems to keep you inspection-ready at all times.
Process Integration
Our team helps build or optimize your QMS to align seamlessly with your operations and scale as you grow.
Ongoing Support
IMEQs provides continuous guidance, training, and updates to help you adapt to changing regulations and industry best practices.
Simplifying Quality & Compliance
IMEQs takes a tailored, proactive approach to embed quality and compliance into your operations. We guide you through every step—from assessing your current systems to ongoing monitoring—ensuring your business meets global regulatory standards efficiently and sustainably.
- Gap Assessment
- QMS Development
- Documentation Support
- Regulatory Strategy
- Training & Alignment
- Compliance Monitoring
Frequently asked questions
We support compliance with major standards like ISO 13485, MDR (EU), FDA 21 CFR Part 820, and other global regulations.
We review your existing quality system and documentation to identify weaknesses and create a tailored action plan.
Yes, we assist with developing quality systems for new devices and optimizing compliance for products already on the market.
Absolutely. We offer customized training to ensure your team understands and follows quality and compliance requirements.
Quality systems should be regularly reviewed and updated—especially when regulations change or your business evolves. We help set up ongoing monitoring processes.