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Quality & Regulatory

The Buffalo Filter team is committed to meeting all regulatory requirements while maintaining an organizational culture that fosters continuous improvement and strives to provide quality products that meet or exceed customer expectations. 

With a proven design control process accepted by partners throughout the world, the quality of your design and your end product is assured. Let Buffalo Filter manage the resource intensive design process and through its lean but effective methodologies, allow us to deliver a quality outcome that is based by solid research and evidence.

Buffalo Filter has extensive expertise in regulatory submissions such as U.S. FDA 510k submissions, MDD Compliance and CE Marking, Electrical Safety Submissions, U.S. CFR820 Design Control Compliance, ISO Design Control Compliance, Canadian CMDCAS certification, as well as other worldwide regulatory registrations and standards.

Our team of engineers, regulatory resources, and quality assurance professionals will guide and manage the regulatory process regardless of your geographic market and will provide your organization with the supporting documents it needs to maintain proper compliance in your chosen market.


  • FDA Registered Facility

  • Quality Management System in place

  • Certified to ISO9001:2008 through SGS North America, Inc - UKAS accredited

  • Certified to EN ISO13485:2012 through SGS North America Inc.

  • Certified to MDD 93/42/EEC Annex V through SGS United Kingdom Ltd., Notified Body for CE Marked products

  • Certified to ISO 13485: 2003 under CMDCAS through SGS United Kingdom, Ltd. 

  • Utilization of ISO 14971 Risk Management Process

  • Health Canada Licensed Products

  • EU Authorized Representative – Emergo Group

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2514 AP The Hague
The Netherlands

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