Bringing a new device to market is one of the most critical milestones for any manufacturer. It’s a driver of growth, innovation, and improved outcomes. In the highly regulated medical device industry, it’s a process with zero margin for error. From concept design to commercial release, every step must comply with strict FDA, ISO 13485, and other global regulatory requirements, while ensuring the device performs safely and effectively for patients.
A successful launch doesn’t just depend on a groundbreaking design – it hinges on whether every supplier in the supply chain fully understands and can meet requirements before production begins.
This is where Requirement Consumption Review (RCR) assessments play a vital role.
What is Requirement Consumption Review (RCR)?
In the medical device sector, RCR is a strategic early involvement process designed to confirm that a supplier has fully “consumed” and can execute all contractual, technical, and quality requirements of a new product build. This involves a cross-functional review—including quality, manufacturing, regulatory, and engineering teams—focused on validating manufacturing capabilities, compliance readiness, and risk mitigation before the first production run.
SQA Services manages RCRs worldwide for medical device manufacturers, acting as an independent partner to align suppliers with client expectations and ensure compliance with regulatory and quality standards.
Why RCR is Critical for New Medical Device Launches
When launching a new medical device, the stakes are uniquely high—patient safety is directly impacted by product quality. An RCR assessment helps safeguard quality, compliance, and timelines by:
- Mitigating manufacturing risks and improving first-pass yields during validation and pilot runs.
- Identifying and addressing design-for-manufacturability issues before they cause downstream quality problems or regulatory delays.
- Ensuring suppliers are prepared for the PPAP process and other industry-specific qualification requirements.
- Verifying alignment between supplier capabilities and critical-to-quality characteristics defined in the device’s design history file.
- Preventing nonconformances during early builds that could trigger costly rework, delayed submissions, or recalls.
The RCR Process for Medical Devices
- Preparation: SQA and the supplier review purchase orders, drawings, quality documentation, and regulatory requirement. This process also includes identifying high-risk components, sterile barrier considerations, and inspection needs.
- RCR Day: A collaborative review (on-site or virtual) where client, supplier, and SQA work through a medical-device-specific checklist. This list covers contract compliance, product design features, build plans, inspection/test protocols, CAPA processes, workmanship, property/tooling management, and packaging validation.
- Action Plan: SQA delivers a detailed report outlining corrective actions for both supplier and client. Follow-up ensures all actions are completed before production ramps up.
The Bottom Line
By uncovering potential risks, resource gaps, and compliance issues early, RCR assessments help ensure that new medical devices are launched on time, in compliance, and to the highest quality standards. This not only accelerates time-to-market but also protects patients, strengthens regulatory confidence, and reduces the likelihood of costly post-market issues.
In the competitive and highly regulated medical device industry, Requirement Consumption by the supplier is a patient safety imperative. It provides the structured, collaborative framework to make it happen.
Protect your next device launch from preventable setbacks
SQA Services partners with leading medical device manufacturers to deliver robust RCR assessments that safeguard compliance, quality, and patient trust.
Contact us today to learn more.
