Medical Device Management & Consulting consulting@regpromedical.com +1 (425) 241 - 3092
RegPro Medical
We know WHAT to do. We do it RIGHT. The FIRST Time.
Design Control
From the first concept of your medical device design, an effective design controls process right from the start is essential to set you up for future success. The regulations and ISO 13485 standard require Medical Devices to progress through a structured design process including planning, design input, design output, design reviews, design verification and validation, and design transfer to manufacturing. Each step in the process needs to be well planned and well documented. The data and documentation generated in these design stages will be indispensable for your regulatory submissions, technical file, and audits and inspections during the whole lifecycle of the product.
What will RegPro Medical Do?
The right Design Control system will keep your product development on track, organized, streamlined, and well-documented. Whether you are in the initial start-up stage or want to improve an existing design control process, RegPro Medical will tailor your design and development process to meet the specific needs of your device technology with maximum efficiency.
When you are ready to kick off a new design or update your existing device, RegPro Medical will help you plan, develop and maintain your design control documentation to meet the standards and regulations, including 21 CFR Part 820.30, and ISO 13485, and to support new and updated regulatory registrations and licenses.
If your design control process and procedure need a tune-up, RegPro Medical will do a detailed review of your process against the regulatory requirements and design custom-made improvements to maximize efficiency and tailored to your organization, device technology, and unique regulatory needs.