Blur Resources
Learn more about Blur Product Development and how our designers, engineers, contract manufacturers, medical device and regulatory experts can help you successfully develop your own products, to your exact needs.
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Medical Device QMS Repository
We understand the challenge and importance of finding the right Quality Management System for your medical device. Knowing what you need to comply with and understanding the regulations is half the battle. Let us do the heavy lifting for you: below are some of the standard operating procedures we use for the development of medical devices. We use these to guide our development and make sure we stay in compliance with the latest medical device regulations.
Disclaimer
The posted SOPs comply with ISO 13485: 2016 and were last updated on September 30, 2024. Blur does not regularly update the SOPs on the website; Documents may be referenced but should not be used as final procedures before confirming compliance with latest medical device regulations.
Quality Manual
The purpose of this manual is to define and describe the Quality Management System, provide general procedures for all activities comprising the QMS, define the authorities and responsibilities of all personnel affected by the QMS, and provide a vehicle to inform our clients of the specific controls that are in place at Blur Product Development to assure continued product and service quality.
Quality Manual PDF
Quality Policy
At Blur Product Development, we succeed by designing, manufacturing, and distributing high quality medical devices, consumer products, and industrial equipment that bring exceptional value to our clients and customers. Our commitment to maintaining the suitability, adequacy and effectiveness of our Quality Management System is essential to our success.
Quality Policy PDF
SOP 7.3 – Design and Development
The Design and Development SOP establishes formal controls to ensure that, for each intended use of a device, the design inputs and outputs are established, the design is developed and reviewed based on the requirements, design verification and validation are completed, and the design is transferred into production specifications.
SOP 7.3 – Design and Development PDF
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Editable Standard Operating Procedures
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EPISODE 1
Regulatory & Product Development
In this video, Christy Coleman, our VP of Regulatory Services, addresses 2 common questions:
1. How does regulatory help product development?
2. How soon should regulatory get involved in the process?
EPISODE 2
Quality & Operations
In this video, Noah Muse, our Director of Quality, and Britt Creech, Director of Operations, address 2 common questions:
- How do you create internal processes that work with your team rather than against them?
- How do you maintain flexibility in a rigid system?
EPISODE 3
Manufacturing
In this video, Britt Creech, our Director of Operations, answers the following question:
When is the right time to involve manufacturing in the product development cycle?
