Quality & Regulatory
Resonetics maintains one quality system across every site and service. This integrated framework ensures all contract services meet specified customer and regulatory requirements, driving consistency, speed, and confidence from concept through commercialization.
“At Resonetics, quality is not just a standard—it’s our promise, woven into every process, every product, and every partnership. In an industry where everything we do can impact a patient’s life, we hold ourselves to the highest standards because our customers expect it and patients deserve it. This unwavering commitment drives us to help the medical device and life sciences industries deliver safe, life-saving innovations to patients around the world.”
Andrea Nicolaisen VP, Quality
Quality Policy
We prioritize patient safety, exceeding customer expectations, and maintaining regulatory compliance.
We commit to delivering effective solutions and services worldwide that enhance patients' lives.
Our employees are empowered to ensure our products meet the highest standards through quality assurance and our culture of Enterprise Excellence.
Global Quality System
Our quality system ensures reliable results in MedTech manufacturing. It brings people, processes, and technology together under one clear framework. The elements below outline how we achieve this across all operations:
Oversight and controls
- Policies, responsibilities, and regular audits ensure compliance
- Validation and production transfer provide documented, reliable processes
- Supplier qualification and monitoring maintain a dependable supply chain
Manufacturing and design
- Production and process controls include documented instructions, inspections, and monitoring to maintain consistent output
- Design controls within the AGILE Product Development® process, supported by risk management and reviews, guide development
- DMR, DHR, and DHF files capture requirements, builds, and design history
Quality and Regulatory Support
Beyond strong internal systems, we provide customer-facing support that accelerates approvals and ensures compliance.
Host pre-approval inspections to support premarket approvals (PMAs)
Provide master file submissions to support customer regulatory needs
Support facility registrations and device listings
