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For Medical Devices & Software (SAMD) Regulations.

For over a decade, Rook Quality Systems has specialized in Quality and Regulatory strategies for medical device clientele.

We offer customized solutions for medical device companies of all shapes and sizes. We work with class I-III devices, including SaMD and IVDs, supporting companies in the early stages of QMS and device creation, from design through commercialization and post-market monitoring.

Rook provides clients with all the right resources and tools to comply with regulations in domestic and international markets. Rook’s team provides expertise in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR and IVDR conformity.

Rook comprises medical device quality and regulatory experts with experience in various medical devices and technologies, including diagnostics, implantables, and wearables. We work closely and efficiently with our clients to meet their quality needs, and ensure that their products meet and exceed regulations and standards.

Our specialties include Quality System Development, ISO 13485, 21 CFR 820, ISO 14971, 510(k) submission, Design Control, Risk Management, CE Mark, Internal and Supplier Audits, CAPA, Complaint Handling, Supplier Approval, Verification, and Validation.

At Rook, we view challenges as opportunities. We take a very analytical and solutions-oriented approach to achieve our client’s goals, relentlessly focusing on efficient and timely problem-solving. What can we solve for you today?

Look to RookQS for all your Medical Device Quality & Regulatory Needs

As a medical device quality systems consultant, we can assist your team with the creation and maintenance of Design History Files (DHF) and Technical Files (TF), ensuring compliance with FDA and international regulations.

We can provide audit support to help ensure that your medical device company meets all necessary regulatory requirements and guidelines, including FDA audits, Notified Body audits, and internal audits.

With expertise in Software as a Medical Device (SaMD), we can help your team navigate the regulatory landscape surrounding digital health technologies, ensuring that your product is safe, effective, and compliant with all relevant regulations.

As medical device quality systems consultants, we can provide support in navigating the complex international regulatory landscape, including product registration, compliance with regional standards, and cultural considerations.

We can develop and deliver customized quality training programs to ensure that your team is up to date on the latest regulatory requirements and industry best practices, empowering them to produce high-quality medical devices.

We can assist in the development of a customized Quality Management System (QMS) tailored to your specific medical device company needs, ensuring that your company is operating efficiently, effectively, and in compliance with all relevant regulations.

With expertise in Quality Management System (QMS) implementation and management, we can help your company manage all aspects of your QMS, ensuring that your medical device products are safe, effective, and compliant.

We can support all aspects of medical device validation, including protocol development, testing, documentation, and reporting, ensuring that your products meet all necessary regulatory requirements and guidelines.

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