Quality Documentation System

At Affinity Life Sciences we take quality very seriously and it is a hallmark of our company. Our Quality Management System is compliant to cGMP and ISO 13485 standards and will meet our strict customer requirements.

Our employees have extensive training and experience in the medical device industry and are chosen based on their commitment to quality and customer service. In order to preserve the trust that our customers have placed in us, all Affinity Life Sciences employees are required to sign a confidentiality agreement prohibiting them from disclosing any proprietary or confidential information to unauthorized parties.

We provide complete transparency of our quality system and your product process including signature authority on all processing related to your manufacturing process from incoming material, validations, processing, storage, and distribution. By working closely with our clients through our Quality Management System, we offer a true partnership in the quality and success of your product.

Compliant Standards

• FDA 21 CFR Part 820 Quality System Regulation – Medical Devices
• ISO 13485 – Medical devices – Quality management systems
• DEA registration number RA0464634: Controlled Substance Registration Certificate

Quality Policy

Affinity Life Sciences, Inc. is committed to faithfully meet our customers’ needs, strictly adhere to regulatory requirements, and provide products and services of the highest quality.