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The management and employees of Affinity Biologicals endeavor to design, produce and distribute quality products.
Affinity Biologicals will maintain a documented quality system in accordance with ISO13485 and 21 CFR820 (Quality System Regulations). This system will identify and comply with the regulatory requirements for in vitro diagnostic medical devices as appropriate to meet our customer’s needs.
The regulatory requirements of Canada (CMDR, Canadian Medical Device Regulations), the United States (21 CFR part 800-861 and 864) and Europe (in vitro Diagnostic Directive 98/79/EEC) will apply to in vitro diagnostic products only.
The following commitments support achievement of our quality policies: