Buffalo Filter: Distributors : Design Engineering & Contract Packaging

Design Engineering & Contract Packaging

Buffalo Filter provides design engineering, product development, device prototyping, testing & validation services, and contract manufacturing/packaging services for projects of all sizes and complexities. Our certified and documented capabilities include assured compliance:

FDA QSR: Design Control, Risk Analysis, cGMP
ISO 9001:2000
EN 13485:2003
Medical Device Directive Annex V
Underwriters Laboratories: IEC/UL60601
AAMI Sterilization and Packaging Validations

Our integrated and audited processes allow for rapid product development. We provide expedited market introduction and penetration within documented and verified project portfolios. These portfolios provide our customers with assured quality systems and regulatory compliance.

We can also provide additional support such:

UL/CE Marking
FDA 510(k) Preparation and Submission
International Licensing and Translation
IP Research and Consultation

Buffalo Filter's project management resources can provide focused project element solutions to complete turn-key product delivery. Our teams of experienced engineering professionals have a well developed background in medical devices and design technologies. Using state of the art development tools, including:

CAD and solid modeling
Stereo lithography (SLA)
Rapid Prototyping
Plastic part and mold design
Metal fabrication and assembly
Electronic interface integration
Graphic/labeling design

We have combined our employees, quality systems, and proven product development experience to help enhance your productivity, lower costs, and compress timelines. Buffalo Filter can help achieve the demanded results and performance you are looking for, regardless of the size of the project.

Buffalo Filter is committed to developing, manufacturing, and the timely delivery of superior products and services which consistently exceed our customers' demands, needs, and expectations.