FAQ

Q) We tested our software, but didn’t document the testing or results; can Rook help?

Definitely. If you’re missing key documentation, we’ll work with you to recreate the “paper trail” needed for audits. The sooner we begin this process, the better.

Q) Does my company need a QMS?

The short answer is “yes”. The slightly longer answer: It’s critical to implement a QMS as early as possible- ideally, before the development of your medical device.

Q) Can Rook help us make our QMS more efficient?

Absolutely. Rook has been pioneering new methods of providing Quality Management for medical device companies and overseeing overall quality strategy for nearly a decade.

Q) Could not having the right quality system in place negatively affect my company’s valuation?

Yes. Not having your Design Control or Risk Management could have a substantial impact on the valuation of your company. Rook can ensure that you have a custom QS in place to ensure compliance with regulatory bodies.

Q) Once we pass our ISO/FDA audits, can Rook provide ongoing management of our quality system?

Absolutely; most of our partnerships are long-term, with Rook continuing to provide QS management post-market.

Q) Is Rook able to work 100% remotely in assisting us with our quality system?

Yes; Rook was the first medical device quality consulting company to work 100% remotely with clients (long before COVID necessitated it). Our quality engineers are also available to work onsite as needed.

Q) Will Rook collaborate with our in-house quality people?

Yes; Rook’s team of highly-trained, experienced quality engineers is happy to collaborate with your in-house quality people to accomplish your specific goals and objectives.

Q) We’ve never had a quality system audit; what can Rook provide in terms of internal audits?

Rook and its team of 11 Certified Quality Auditors has been conducting internal or supplier audits, and providing support during an external or regulatory audit (including FDA, MDSAP, ISO 13485:2016, and MDR audits) since 2012. For more information, here’s our recent blog on the importance of internal audits

Q) When you work with a new client, what does that work plan typically look like?

The first step in working with a new client is to establish the company’s regulatory plan and desired timeline for the project, and clearly define the level of support RQS will provide to help achieve these goals.

Q) Can you tailor a QMS for SaMD?

Yes. Rook has been providing customized consulting services for all classes of medical devices, including Software as a Medical Device (SaMD), for nearly a decade. That includes extensive experience writing 501(k) for SaMD products.

Q) Can Rook begin with a gap analysis before a formal audit?

Definitely. In many cases, it makes sense to begin with a gap analysis and identify any data/documentation gaps. We recommend starting with a requirement review, which includes a user, system, and software level analysis.

Q) Our early documentation isn’t in the QMS; can Rook help?

Yes. Rook can help to create your device Design History File and/or Technical File to ensure compliant design control, risk management, design transfer, and manufacturing oversight.

Q) What kind of medical device companies do you work with? Custom devices? SaMD? 3D printing?

All of the above. Rook has been working with a wide range of devices (including custom devices, SaMD, 3D printing, and IVDs for nearly a decade.

Q) How do Rook’s services coincide with an eQMS tool?

Rook’s team has years of experience evaluating all available eQMS tools. Our services complement an eQMS; to use an analogy, the eQMS tool is like QuickBooks, and our team acts as the “auditors” to ensure compliance; detecting any errors, and confirming the filings are complete and accurate.

Q) Can Rook create a 510(k) for a SaMD product?

Yes. Rook has extensive experience creating 510(k) for premarket SaMD and monitoring products.

Q) We can’t keep track of all the FDA premarket submission updates; can Rook monitor these for us and keep us up-to-date?

Yes. Rook continuously and carefully monitors all FDA updates so that we can advise our clients accordingly.

Q) We have a large validation project; can Rook provide comprehensive on-site support?

Yes. Rook’s team of 20 quality engineers is highly experienced in large validation projects, and available to provide both remote and on-site support as needed.

Q) We need a partner that can be very hands-on; can Rook support us during a FDA/external audit?

Yes. Rook’s robust team of seasoned, expert Certified Auditors can be as hands-on as necessary in providing comprehensive preparation for a FDA/external audit.

Q) Which classes of medical device do you support? In which countries/markets?

Rook supports a wide range of devices (including class I-III) and provides expertise in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity. We have a proven track record of working with medical device clients based in the U.S., Canada, the UK, Europe, and Asia.

Q) We’re not exactly “experts” on the QMS requirements; can Rook complete all the necessary documentation?

Yes: Rook has a decade of QMS expertise. Our team will create a custom QS for your company that is efficient and easy to maintain for your product and scope. Our systems are audit ready, and continually updated to ensure compliance with effective regulations.

Q) Can you help us with writing test protocols and developing trace matrices?

Absolutely; we have a decade of experience helping medical device partners write test protocols and create trace matrices for 510(k) submissions.

Q) Does the Rook QMS include a fully executed validation package that meets the most stringent compliance audits?

Yes. And our systems are continually updated to ensure compliance with the most stringent regulatory body audits.

Q) We’re concerned about the FDA potentially finding a flaw (or worse yet, “flaws”). Can Rook help?

Absolutely. Our advice is to always be proactive rather than reactive; the Rook team of 11 Certified Auditors will help you identify any and all potential flaws in advance of an audit, so that you emerge with zero findings.

Q) We’re feeling a little overwhelmed by all the regulatory jargon and acronyms thrown at medical device companies; can Rook help us translate all the jargon into plain English?

We can empathize, so we created a glossary of regulatory terms to help with translation. If the term or acronym you’re searching for is not listed here, please let us know and we’ll respond in a prompt and timely fashion.

Q) Should we take a proactive approach to managing CAPA processes?

Yes, we highly recommend being as proactive as possible in defining and managing your CAPA processes. We have extensive expertise with CAPA Form and Logs, and work with our partners to ensure timely and seamless CAPA processes.

Q) So, if we didn’t document it, did it actually happen?

Unfortunately, as far as the FDA and other Regulatory bodies are concerned, no, it didn’t (even if it did). Rook helps clients compile and maintain Quality Records- documents that detail the history of actions taken to maintain regulatory compliance.

Q) Can Rook help us translate FDA-ese to plain English?

Yes, we are fully fluent in “FDA-ese”, and all other variations of “regulatory-ese”, and will make sure absolutely nothing gets lost in translation.

Q) We don’t know exactly what the regulatory agencies require: Can Rook help?

Yes. Rook has nearly a decade of working with all the major regulatory agencies, so we know exactly what each one requires, and exactly what you’ll need to provide.