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Partner Case Study

Aptitude Medical Systems


Aptitude Medical Systems is a startup healthcare company specializing in deep-tech. The company has approached Rook Quality Systems to complete the design transfer process. Recently, Aptitude was awarded by Biomedical Advanced Research and Development Authority (BARDA) to develop diagnostics for point-of-care and at-home use. The product Aptitude has developed is the first FDA-authorized molecular diagnostic test that can work with saliva or swab samples for at-home and over-the-counter use without physician supervision. Transferring the product design to actual production is a critical and inevitable step. However, there may be significant challenges along the way. Communication gaps, especially language and technical jargon differences, can result in misunderstandings and delays. Validating manufacturing processes and ensuring supplier quality are essential but complex tasks. Quality assurance is equally vital, with incomplete documentation, late design changes, and quality issues posing potential challenges. Aptitude Medical Systems has shown good foresight by engaging Rook Quality Systems’ services early in the design transfer process.

Scope of Work

Aptitude requires assistance from RookQS for the design transfer with suppliers, including transferring outsourced firmware design to Aptitude’s quality management system and converting product requirements to device master records (DMR) for supplier production.

It is confirmed that the equipment needed for production has been validated, including installation, operation, and performance qualification (IQ/OQ/PQ), along with the manufacturing and quality process instructions, and that all device history records (DHR) forms are complete.

Near the end of the design transfer, Aptitude required on-site supplier audits for critical suppliers to guarantee FDA QSR and ISO 13485 compliance. RookQS and Aptitude worked together to establish a list of significant manufacturing and quality procedures specific to each supplier to focus on during audits. The audit occurred for three days, during which two RookQS auditors visited the suppliers to review their quality manual, quality procedures, work instructions, and relevant records. Furthermore, the auditors conducted a facility tour to ensure that there were no instances of non-compliance at the actual work site. After the audit, Aptitude and the suppliers received an audit report along with proposed remediation to address the identified issues.


RookQS first established a standard DMR list and then discussed with Aptitude which items would be provided by either Aptitude or suppliers. Based on the list, RookQS reviewed the DMR and relevant device history records (DHR) from suppliers to ensure they met the requirements of the quality system. In case of any noncompliance, RookQS collaborated with suppliers in the weekly meetings to address the issues. During this process, RookQS noticed that some suppliers were not familiar with QMS. Therefore, RookQS also assists in establishing relevant processes like process validation and quality control. During conversations with Aptitude and the suppliers, the primary issues often center around achieving the ideal equilibrium among timing, quality, and expenses. Specifically, it involves adhering to regulatory standards while implementing timely modifications without excessively interrupting the supplier’s established processes. Through handling the design transfer documents, RookQS has acquired valuable insights into the supplier’s procedures and their level of familiarity with the quality system. As a result, critical audit items are identified in advance and harmonized with Aptitude.

As part of the on-site audit, RookQS conducted observations of the actual production environment and equipment, as well as held interviews with employees. These details, which cannot be fully captured in records, enable Aptitude and RookQS to gain a better understanding of the supplier’s capabilities and compliance. On the other hand, the requirements from Aptitude can also be comprehended by suppliers through auditor interviews with personnel from the quality, manufacturing, and research and development (R&D) departments of the supplier. Upon completion of the audit, RookQS prepared a report and collaborated with the supplier to develop a remediation plan. Through the process of conducting on-site audits and gaining familiarity with the supplier’s quality system, personnel, and local factory culture, RookQS can help suppliers with remediation more efficiently.


With RookQS serving as a liaison between Aptitude and their suppliers, the communication gap is significantly alleviated, all design transfer activities are well completed, and comprehensive documents are generated. In addition, through conducting on-site supplier audits, Aptitude gains insight into the forefront of production and establishes effective communication channels with the suppliers. Consequently, the design transfer process is completed seamlessly, enabling Aptitude to introduce its product to the market, one that not only complies with regulatory requirements but also aligns with the desired quality standards.

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