RMRQP specializes in building quality management systems for start-up medical device companies. The quality systems built by RMRQP are compliant with ISO 13485:2016 and 21 CFR Part 820, with the addition of the EU MDR, MDSAP, Health Canada, and other markets available.

In early 2022, the quality management system RMRQP built and ran for a small start-up client was certified as a full medical device manufacturer per ISO 13485:2016 by the notified body GMED. While this was the 2nd complete quality management system built by RMRQP, this was the 1st that achieved their ISO 13485:2016 medical device manufacturer certification.

RMRQP operates all modules of a medical device quality management system and has staff available to fill any of your QMS needs. From complaint handling to CAPA close out, from receiving inspection to final production release, from document control to management reviews, RMRQP has staff available with experience in all elements of a medical device QMS.

RMRQP has a number of certified quality management system auditors available to conduct the audit of your choosing. RMRQP works with a former FDA medical device Quality System Inspection Technique (QSIT) auditor available to conduct your pre-audit inspection and provide feedback prior to your official ISO 13485 (or FDA 21 CFR Part 820) audit.

Does your organization struggle with medical device design and development risk management activities, or how to evaluate risk in post-production environment? Is your risk management system integrated into your post-market surveillance, post-market clinical follow-up, and clinical evaluation plans? RMRQP has extensive experience in all thing’s medical device risk assessment and management, including performing all risk planning, risk assessment, and risk control activities for various medical devices per ISO 14971:2019. The RMRQP suite of risk management SOPs and templates has been audited for ISO 13485:2016 and were certified by a notified body.

Have you ever wondered which requirements need to be verified and which need to be validated? Do you need help determining how to validate your design, packaging, equipment, manufacturing line or manufacturing facility? RMRQP can help with any size project from assisting with a single protocol/report to designing and executing your entire master verification and validation plan.

RMRQP has multiple employees dedicated to document control. RMRQP utilizes IMSXpress as the online quality management system documentation provider of choice for our clients. With a complete set of SOPs explaining and using IMSXpress, RMRQP can insert its ISO 13485:2016 certifiable document control SOPs directly into your quality management system for quick, complete, and affordable online document control and documentation system. One reason RMRQP likes and utilizes IMSXPress is because it removes many of the previous paper documents that needed to be created to record activities within the quality management system, and with this system the documentation the activities of a QMS can take place almost entirely within IMSXPress. RMRQP has employees available to conduct your document control activities for you using IMSXpress or whatever your document control system may be.

RMRQP has extensive design experience creating labels for all types of medical devices. If you need an Instructions for Use / User Manual, device labels, case labels, kit labels, IDE labeling (Informed Consent, Investigator’s Agreement), UDI, or other labeling, RMRQP will able to draft labels that meet applicable regulations for content and symbology.

Do you have a new medical device that requires UDI but you don’t have a system in place to develop your own UDI? RMRQP has procedures you can integrate directly into your quality management system with step-by-step instructions and activities that are needed to obtain your complete UDI and Basic-UDI-DI.

Do you need to register UDI and Basic UDI in GUDID or EUDAMED databases? RMRQP can assist with ensuring that accounts are obtained, and accurate information is provided to both databases.

FDA and other regulatory bodies require statistically relevant data in support of a products safe and effective use or a processes reliability in performing a function. RMRQP has experience meeting these requirements as well as statisticians available to help with determining your sample size calculations, including for manufacturing validation or design validations, such as clinical trials.

RMRQP has performed multiple recalls. RMRQP has a full set of ISO 13485:2016 certifiable medical device recall procedures (which were in 2022 certified for another client) and templates available for purchase. These recall procedures and templates can be seamlessly integrated into any medical device quality management system. RMRQP has a proven track record of completing FDA required recall activities in the required time frames; our SOPs and templates make documentation and communication of recall activities as easy as possible.

Regulatory submissions of any type have a minimum set of requirements necessary for regulatory bodies to accept the information for review. Oftentimes times these submissions are very large and have inputs from many different departments within a company. All these activities must coordinate in order to provide the correct message to the regulatory authority or auditing agency involved in your project.

As most medical product manufacturers know, navigating the regulatory and quality hurdles associated with legally marketing a new medical product in the United States can be daunting. Furthermore, navigating international regulations can be downright overwhelming. RMRQP has extensive experience in US, Canadian, and EU (among others) regulatory and quality strategy and is available to help you today.

A comprehensive regulatory strategy includes:

1. Determining if your product is a medical device

2. Identifying potentially exclusionary rules or regulations

3. Identifying the medical device class (US, Canadian, and EU) and / or classification (US only)

4. Identifying the product code (US only)

5. Identifying the predicate device(s)

6. Identifying required testing, design, or manufacturing standards

7. Determining appropriate product testing to be conducted and included with the submission

8. If needed, determining QMS requirements and putting together a strategy and plan

9. Are you having trouble determining if your product is regulated as a medical device in the US or EU?

10. Do your competitors have 510(k) clearance for their product(s), but you don’t? Are you being asked by buyers to provide evidence of domestic clearance? Are you trying to gain a competitive advantage over your competitors by obtaining market clearance first? Is it unclear to you the relationship between your marketing strategy and the content of your 510(k) submission?

The background RMRQP offers includes researching and authoring strategy for over 100 different types of medical products of varying complexity, including in vitro diagnostic devices (IVDs), combination products, convenience kits, CLIA/CAP laboratory, cardio-pulmonary bypass equipment, thermoregulation systems, surgical catheters, thoracic surgical products, general surgical products, cardiac surgical products, mammographic X-ray systems, computed tomography x-ray systems, colonoscopes, percutaneous transluminal angioplasty catheters, laser ablation catheters, various surgical implants and surgical tools, dental implants, urological catheters and accessories, medical gloves, oximeters, hearing aids, numerous electrosurgical products, software products, ablation systems, and personal lubricants, among others. Utilize this breadth of experience today to know, once and for all, if and/or how your product is regulated.

If you’re unsure of the regulations, don’t tackle this important element of your business plan on your own. RMRQP offers competitive pricing designed for the small business owner’s budget. Ask what we can do for you in 20 hours.

RMRQP has experience obtaining market approval in most worldwide markets. While RMRQP does not operate in countries outside the United States, we regularly provide documentation to regulatory counterparts abroad, such as for distribution centers that also provide authorized representative services. The quality system RMRQP has built can support marketing applications in the following markets: United States, EU, UK, Health Canada, Mexico, Central America, ANVISA, Australia / New Zealand, and Thailand. RMRQP has limited experience with China and Japan.

FDA is increasingly relying on the pre-submission (Q-sub) program. This program directs current and future medical product manufacturers to write to FDA and request official feedback prior to submitting an actual application to any FDA office, including 510(k), PMA, IDE, NDA/ANDA, IND, and BLA.

FDA does not accept all requests for feedback. FDA has a series of requirements for the type of information required based on the feedback desired, and if your information request doesn't include the required elements, or you don't provide required information in a timely manner, FDA will reject your information request or cancel your meeting.

RMRQP has extensive experience communicating with FDA and knows what information FDA requires in a Q-sub to receive meaningful feedback.

RMRQP has a 100% success rate in obtaining on-time FDA feedback, including the form of written responses, teleconferences, and face-to-face meetings at FDA headquarters.

If you're concerned about directly discussing your product's regulatory strategy with FDA, let RMRQP contact the FDA on your behalf to discuss your submission strategy and their potential submission requirements.

If you have received an official communication from FDA but have not yet formulated a response and need to do so by a specific deadline, contact RMRQP today for assistance.

RMRQP has written many different communication letters to the FDA. With changes to the FDA’s processes in regard to evaluating new devices or changes to existing devices, early and frequent communication with FDA is even more important, relied upon, and expected by FDA. RMRQP has written many dozens of these communications and knows what information is required and how to present that information in order to obtain the most helpful information from the FDA reviewers. RMRQP is available to help craft your communications to FDA to ensure the feedback you receive moves your project forward.

RMRQP developed design control SOPs also incorporate the tasks of obtaining feedback from regulatory agencies as part of the process of collecting design inputs; these SOPs are available for purchase by clients of RMRQP.

Conducting a IDE clinical study requires compliance with 21 CFR Part 812, the regulation for investigational device exemptions. Obtaining an IDE does not need to be time consuming and costly. With a 100% track record of obtaining IDE clearance in 30 days, contact RMRQP today to discuss how to get your clinical trial approved by FDA in time to meet your enrollment deadlines.

RMRQP authors and submits 510(k) premarket notification applications for new Class I or Class II medical devices. Having authored numerous 510(k) applications for different medical products, RMRQP offers a broad spectrum of experience and insight to help you put together a 510(k) application that will withstand, and pass, FDA scrutiny and review.

1. Have you spoken with FDA yet about your product and submission?

2. Do you need a pre-submission (Q-Sub) sent to FDA to obtain initial feedback?

3. Have you obtained FDA feedback via the Q-Sub process and are trying to implement their feedback into your submission?

4. Do you find the requirements for FDA’s Refuse to Accept Checklist or the e-submission process confusing and are unsure how it applies to your product?

5. Do you have questions on which sections of the 510(k) application apply to your product?

6. Is it unclear to you what product test data needs to be included in your application?

7. Are you having a tough time determining your predicate device(s)? Or what testing of your product needs to be compared to the predicate(s) of choice?

8. Does your submission need to include comparative testing?

9. Do you need to identify appropriate testing labs?

10. Do you question which standards apply to your product or how to fill out FDA forms relating to standards referenced in your 510(k) application?

11. Do you find the expectations for documented standards compliance unclear?

12. Do you need someone to take your existing documentation and assemble it into a complete submission that will get through FDA’s Refuse to Accept Checklist and on to the substantive review process?

13. Are you on a tight timeline for FDA clearance?

With FDA’s ever-changing expectations for new medical product applications, RMRQP is your partner in successfully navigating the FDA’s process for legally marketing your product in the United States. Don’t get stuck in FDA’s revolving door of questioning that can extend 510(k) clearance for months, if not years. Contact RMRQP today to discuss your 510(k) submission strategy.

RMRQP has created a series of templates proven to meet FDA’s expectations. Don’t start from scratch writing a submission that may not contain the required elements, utilize RMRQP’s 510(k) templates today to get your product through the FDA on their quickest timeline.

With all our best intent in an original 510(k) application, FDA rarely clears a product without requesting additional information. At times you may wonder if FDA even read your application based on their questions, where other times they may be challenging the sufficiency of your data in support of safety or substantial equivalence. Both of these situations require careful consideration and a well written response.

With FDA's updated practice of allowing only a single Additional Information (AI) Response before rendering their SE / NSE determination, it is increasingly important to effectively respond to FDA AI questions the first time. Responses to FDA AI questions need to be well crafted, thorough, and concise, while leaving no point unaddressed.

RMRQP has worked with numerous medical device manufacturers, of varying device types, answering 510(k) additional information requests. To date, all FDA AI responses we have written have led to subsequent 510(k) clearances.

RMRQP has extensive experience addressing FDA questions of all types, from those relating directly to product testing and determination of acceptance criteria, to those relating to regulatory and marketing strategy.

RMRQP has worked with FDA on determining bench, animal, and clinical trial requirements, as well as have successfully justified how data supports product safety and efficacy and / or substantial equivalence.

If your company is looking for help with their 510(k) remediation, contact RMRQP today to discuss your strategy for completing your 510(k) submission and obtaining FDA 510(k) clearance.

PMA applications include a well prescribed set of documentation that may take a year or more for FDA to review, and thus often a year or more for a company to create. With PMA requirements including elements of design control and design verification and validation, and also manufacturing design and manufacturing verification and validation, ensuring all PMA requirements are met is a considerable undertaking that will often take a small team of people to complete. RMRQP can provide that team of people and can ensure your PMA application meets the requirements for substantive review.

Since PMA applications often include clinical trial data, it is highly recommended a manufacturer who has a device requiring a PMA submit a Q-Sub prior to beginning the clinical study to ensure FDA agrees that the trial design supports the proposed intended use statement.

Class I, I s/m, IIb, and III devices require a CE mark to market the device in the EU. Some devices can obtain self-certified CE marks, where others require certification of the device technical documentation by a certification body to apply a CE mark. In either case, the documentation for completion of the product design, testing, and manufacturing, including the clinical data, is required prior to putting the device on the European market. The documentation is preferably assembled to create a Summary of Technical Documentation (STED), which is then provided to the certification body for review and subsequent CE marketing. CE marking certification bodies accept the STED format as the assemblage of technical documentation.

The quality management system created by RMRQP includes the development of documentation needed for CE marking.

RMRQP is now offering Medical Device Regulation (MDR) 2017/745 Technical File Remediation. RMRQP has conducted many technical file updates to the latest MDR regulations and is prepared to do the same for you. With some notified bodies no longer conducting MDD updates as of first quarter 2019, if a CE certificate expires any time after December 31, 2018, some may only have the option to update their certificate (and thus QMS documentation, as appropriate) to the new MDR.

RMRQP can provide a team of regulatory and quality professionals trained on the gaps between the MDD (93/42/EEC) and upcoming MDR (2017/745), to conduct a gap analysis of your technical documentation and advise on the updates to historical data, including your clinical evaluation reports (CERs). We have gap assessment tools and an updated General Safety and Performance Requirements checklist (previously known as the Essential Requirements Checklist) ready to apply to your products.

Ensuring all elements of a CE Technical File for a medical device or in-vitro diagnostic (IVD) are met doesn't need to be difficult. Negotiating with EU notified bodies can be easier when you understand their requirements and know how to meet them. Have a plan ready when you go to your notified body to discuss how you will meet the latest MDR - RMRQP has a plan for you.

RMRQP is available to help with the following:

Determine what changes need to be made to meet the new MDR or the IVDR. Do you need a complete overhaul of your technical file for historic products that haven't been touched in 30 years? Or are you preparing your first technical file for a new product and want to meet the MDR / IVDR with your first CE marking audit? RMRQP has a plan.

Determine if your historical standard testing data reports meet the latest testing requirements set out in the new MDR / IVDR? Remember, there is no grandfathering of old data without justification; notified bodies are going to be looking for evidence showing you meet the latest standards - be prepared to show them how you do that. RMRQP has a plan. Human factors testing will be requested by a notified body.

Do you have Post Market Surveillance and Post Market Clinical Follow-up plans in place? If you have no historic clinical data on legacy products, notified bodies may accept PMCF data to supplement your file to meet the new MDR, but you need to start collecting that data now. Get your PMCF program up and running and start collecting data now that you can use for your CE marking to the new MDR in time.

Can you really show technical, biological, and safety equivalence of your product to a competitor’s product? Notified bodies will now expect you to have all the technical documentation necessary to show equivalence, including design documentation, in order to claim equivalence. To put simply, you'd have to have access to your competitors complete DHF. Do you have a plan to show equivalence of your historic / legacy products to another companies’ product? If you can't do that, consider using PMCF now to obtain the data you need to complete your certification updates.

Audit your QMS per ISO 13485:2016. This comes first. Notified bodies are no longer certifying the previous revisions of ISO 13485. Many companies are obtaining their updated ISO certification first and completing the technical file updates per their newest procedures. Provide this update plan to your notified body, along with your plan for updating your technical files. RMRQP has a plan.

Other CE tasks:

To discuss these and other aspects of CE marking your medical product or IVD, contact RMRQP today.

1. Does your product meet the definition for a medical product in the EU?

2. What class is your medical product?

3. Does self-certification apply to your product?

4. What Technical File content do you need to have for your new product?

5. How to document compliance to recognized consensus standards. How to select the appropriate notified body.

6. Identify content for Declarations of Conformity.

7. Determining the appropriate conformity assessment procedures for my new product.

8. Determining if you have the appropriate quality system to support your product in the EU and elsewhere?

The effort of putting together a well-designed clinical trial that will support a regulatory filing for a new intended use can be a daunting task. Oftentimes finding a place to start the process is a barrier in-and-of itself. Bring your questions about clinical trial design, statistical methodology, informed consent, and institutional review board applications to RMRQP to get the feedback you need.

Contact RMRQP today to learn more about these processes and available resources to get your clinical trial and IRB application off the ground.