Haemonetics Software Solutions Division provides consulting services for custom software development, validation and regulatory projects on either a fixed fee or time and expense basis.

Custom Software Development

Software development consulting utilizes Haemonetics' proven software methodology to collaborate with the customer, design system specifications, and develop products.

Validation

Haemonetics' extensive experience in the testing and validation of our own 510k cleared software products allows us the unique opportunity to assist customers in their validation and testing strategies. We have developed a guideline that emphasizes process validation and includes all the relevant aspects of a computer system implementation: hardware, software, personnel, procedures, and overall documentation of the implementation process.

Regulatory

Haemonetics' Regulatory consulting includes comprehensive technical and compliance-oriented program management services. Our expertise includes strategic quality and compliance management, cGMP/QSR assessments and audits, total computer systems and 21 CFR Part 11 compliance, and preparation of software related information for 510k submission.