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5 Questions to Evaluate your Records v. Documents Management Practices

5 Questions to Evaluate your Records v. Documents Management Practices

Documents, documents everywhere.  But which are the records, which are documents—what is the difference and why does it matter? Even start-up medical device companies are neck deep in documentation.  In addition to documents generated during the creation and production of a product or combination device, additional documentation is generated while working with the FDA Q-Subs, submissions, and Quality System Regulations. No question about it, it’s daunting….and often misunderstood.  One common confusion we hear frequently is the difference between a “document” and a “record”, and how each should be managed.  Keep reading for insights into the difference between the two and best practices to help you manage each. 1. Documents vs. Records:  What’s the Difference? In short, records are a subset of documents. More specifically: Document: For a medical device company, a Document satisfies a regulatory need or requirement and is most often called a “Controlled Document.”   A Controlled Document is a reference document, which through the course of its lifecycle may be reviewed, modified and distributed several times. Controlled Documents may include documents and information for public disclosure including, but not limited to, marketing, sales and promotional materials, training materials, clinical and technical information, labeling, and product related documents such as manufacturing procedures. Record:  For a medical device company a Record is a document created to demonstrate both quality system conformance to specified requirements and the effective operation of the Quality Management System (e.g. Change Requests, CAPAs, etc.).  They are documents that provide objective evidence of activity performed, or results achieved, during the design, development and production of regulated product(s). This can include verification, validation data sheets, DHR records,...
Take the Document Control System Quiz (SPOILER: it’s pass/fail there’s no partial credit)

Take the Document Control System Quiz (SPOILER: it’s pass/fail there’s no partial credit)

How do you know your Document Control System is working properly within your medical device company? Take this quick Document Control Health Check-Up Questionnaire: Do you approve (via wet or electronic signature) documents prior to issue? If you use electronic signatures, have you thoroughly assessed their function for 21 CFR Part 11 compliance? Do your document changes go through an approved change control process? Are document changes reviewed by the same person or personnel within the same function who previously reviewed and approved the document? Are your changed documents formally approved again? Do you consistently issue unique revision numbers to documents according to established procedures? Do you consistently document a description of changes to documents according to established procedures?  Are approved documents available at point-of-use for affected personnel? Are documents of external origin identified and is their distribution controlled? Do you effectively prevent the use of obsolete documents? Are your documents backed up to ensure efficient retrieval in the event of disaster? Have you validated your document control process or your electronic document management system as appropriate? If you answered—without hesitation—“Yes!” to all these questions, you are in great shape. Congratulations! If you answered “No” or “Maybe”, or if you had to pause and really think about the answer, then you might need some assistance.   The amount of controlled content created by a medical device company is extensive.  Lack of document control can create regulatory risks, risks to your Intellectual Property, and erodes the value of your operations and assets. Don’t wait for an audit or adverse event to assess and improve your Document Control System. If you need...
Regulating Medical Devices Shapes Industry for the Better

Regulating Medical Devices Shapes Industry for the Better

This article originally appeared in Business Worldwide magazine. It’s fashionable to be anti-regulation in business today. But sometimes regulation is central to how a sector operates. We talk to Rita King, CEO of MethodSense and Russ King, President of MethodSense about why regulating medical devices and biotech/pharma companies is so critical. Most devices and innovations need to go through a complex system of regulatory approval. In order to obtain market entry, some argue that regulatory agencies like the US-based Food and Drug Administration (FDA) are too zealous, preventing or delaying life-saving innovations from entering the market. Richard Williams, an affiliated scholar at the Mercatus Center at George Mason University, cites an example where three medical devices submitted for approval took nine years to process. He argues that it costs on average $24 million to manage FDA requirements. “A mid-1970s law,” he argues, “requires virtually every medical device—and improvements to existing devices—to endure a slow, expensive, uncertain approval process, ill-suited to 21st-century technology. The Food and Drug Administration (FDA), which grants such approval, has an ageing structure and culture that adds extra layers of discouragement to would-be innovators.” But what are the benefits of regulation, and how can pharma and tech companies manage the process of compliance more smoothly? MethodSense is a company that exists to assist companies with FDA and other regulatory agencies to obtain market entry for their medical device products. We talked to Rita King, CEO of MethodSense, and Russ King, President of MethodSense, about what they do and why regulation matters. What kinds of services do you provide as a company? “MethodSense’s consulting service approach is a little...
MethodSense Inc. CEO WiMethodSense Inc. CEO Wins Global Leadershipns Global Leadership Award with Business Worldwide Magazine

MethodSense Inc. CEO WiMethodSense Inc. CEO Wins Global Leadershipns Global Leadership Award with Business Worldwide Magazine

We are pleased to announce that CEO Rita King was named “Healthcare CEO of the Year – USA” by Business Worldwide Magazine. Full text of the press release is below… LONDON, October 4, 2018 /PRNewswire. The chief executive of life science consulting firm MethodSense has gained global recognition for outstanding leadership in the Business Worldwide Magazine (BWM) 2018 CEO Awards. Rita King was named ‘Healthcare CEO of the Year –USA‘ for her sterling work at the helm of the North Carolina-based company. The 2018 Business Worldwide CEO Awards identify and honour the Most Respected C-level executives across the globe from a variety of different sectors. Unlike many business awards that focus on the overall achievements of specific companies, the approach here is to focus instead on the personalities at their helm, inspiring others to achieve similar successes. MethodSense offers life science and medical device regulatory compliance; guiding medical device, biotech and pharmaceutical companies and supporting them through the commercialisation process and beyond. It’s an industry that’s notoriously difficult to navigate, with many submissions taking years to be approved by regulatory bodies like the Food and Drug Administration (FDA). Through their comprehensive methods, MethodSense assists in all aspects of regulation, compliance and commercialization efforts. MethodSense seeks to simplify the process of bringing, or keeping, a medical device or combination product to market, enabling them to commercialize their innovations. In a career spanning more than 26 years, Rita King has garnered an impressive international reputation as a regulatory expert. She has participated in numerous national and international committees and is a founding member of the Underwriters Laboratories team. A highly sought-after speaker, her thoughts on...
Artificial Intelligence and the FDA

Artificial Intelligence and the FDA

The tech world is exploding around the realities and possibilities of Artificial Intelligence (AI). Artificial Intelligence makes it possible for machines to learn from experience, adjust to new inputs and perform human-like tasks reflecting what we normally think requires natural intelligence.  There are currently relatively few FDA cleared products that use Artificial intelligence on the market.  But the use of AI in the development of medical devices is accelerating dramatically because AI holds a great deal of promise for solving health problems. But as a relatively new tool for medical device developers and with rising interest in applying AI to solving health problems, what is the FDA concerned about? FDA and Artificial Intelligence In general, the FDA is seeking to ensure the safety and efficacy of new devices using AI while doing so in a way that doesn’t hamper innovation. This balancing act is nothing new for the FDA; but how the FDA is managing safety and efficacy for medical devices incorporating AI is undergoing refinement. The FDA has its traditional concerns about AI as a software tool: validation, software development lifecycle management and documentation, the need for well controlled study designs, etc. But AI also presents some new, interesting challenges: AI programs often depend on real-world benchmark data as original inputs. The real world is notorious for its variability, so how do you justify the benchmark data chosen?How do you insure that the benchmark data chosen supports the intended use of the device?If you need to re-train your AI algorithm with new real-world data, what does that mean for the status of the device as a cleared medical device?There are different kinds of...
Advocate v. Adversary: why your perception of the FDA can affect your submission

Advocate v. Adversary: why your perception of the FDA can affect your submission

Ensuring a FDA 510(k) submission is done properly is critical to getting your medical device into the market and monetizing your development. And the speed with which you complete your submission can drive significant business value. Timeliness is key, as is completeness and accuracy. This is the business value we seek to bring to our clients. For one client we were able to get the submission done far ahead of schedule and in the face of the FDA doubting the ability to achieve product clearance.  We believed we could be successful and ask the FDA to work with us on the success path we could see in front of us.  The FDA agreed and because we believe in building appropriate relationships with FDA reviewers all parties experienced success. While at the FDA for another project, we requested a brief discussion with the client’s reviewer while visiting the FDA on another matter for the simple purpose of enabling understanding.  After a very brief discussion with the reviewer, we were able to better understand how to meet the reviewer’s expectations.   The reviewer also better understood the client’s perspective and goals.  Our brief “out of process” meeting created the foundations for better communication which further accelerated the submission review and 510(k) clearance. A collaborative and comprehensive approach to FDA 510(k) submission If you look at the FDA as a roadblock or adversary, your mindset will influence the way your approach those interactions. MethodSense believes a collaborative and comprehensive approach to submissions delivers the best business value. A well-done 510(k), combined with confidence and positive view can greatly simplify the process.  And MethodSense...
FDA Announces FY 2018 MDUFA Fees

FDA Announces FY 2018 MDUFA Fees

MDUFA Fee Increases and FDA Small Business Certification The FDA has recently announced the fee rates and procedures for medical device user fees for fiscal year 2018 in the Federal Register. Under the FD&C Act, as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA is authorized to collect user fees for certain medical device applications, submissions, reporting on class III devices and fees for establishments subject to registration. These fees are in effect from October 1, 2017 through September 30, 2018. 2018 MDUFA Fees FDA user fees have increased across all categories. This increase will substantially impact larger companies. Most FDA user fees increased 33%; however the standard application fee for a 510(k) submission rose 125% to $10,566. The increase in fees is a result of inflation adjustment plus any additional increase FDA feels is necessary to reach the inflation adjusted total revenue amount the agency has identified for the year. Application Type 2018 Standard Fees 2018 Small Business Fees 510(k) premarket notification submission $10,566 (+125%) $2,642 (+13%) 513(g) request for classification information $4,195 (+33%) $2,098 (+33%) Premarket application (PMA) $310,764 (+33%) $77, 691 (+33%) De novo classification request $93,229 (new) $23,307 (new) Annual fee for periodic reporting on a class III device $10,877 (+33%) $2,719 (+33%) Annual establishment registration $4,624 (+37%) $4,624 (+37%) Qualifying for Small Business User Fees At the same time that the FDA announced their 2018 fees, they also updated their guidance FY 2018 Medical Device User Fee Small Business Qualification and Certification. A business that is qualified as a “small business” is eligible for reduced user fees. A small...
FDA Announces New Policy for Accepting Consensus Standards for Medical Devices

FDA Announces New Policy for Accepting Consensus Standards for Medical Devices

FDA Streamlines Process for Accepting Consensus Standards We are seeing the impact of the 21st Century Cures Act yet again with FDA’s clarification on how they will process requests for recognition of consensus standards. With this new policy, FDA has streamlined the process that allows medical device manufacturers to submit a request to the FDA for recognition of a standard that has been established by a nationally or internationally recognized standard organization. What Are Recognized Consensus Standards A recognized consensus standard is a national or international standard that FDA has evaluated and recognized for use in satisfying a regulatory requirement and for which FDA has published a notice in the Federal Register. Many consensus standards address aspects of safety and effectiveness that are relevant to medical devices. When a medical device manufacturer is submitting a premarket application, such as a 510(k), Investigation Device Exemptions application (IDE) or a Premarket Approval application (PMA), it must demonstrate to CDRH (Center for Devices and Radiological Health) that their device is safe and effective. Applicants may be able to demonstrate safety and effectiveness by conformance to FDA-recognized consensus standards. When planning performance and safety testing, manufacturers should review the list of FDA-recognized standards to determine if the standard they are considering is listed. FDA recommends that plans to conform to particular standards be discussed during pre-submission meetings. If testing has already been conducted to a standard not recognized by the FDA but acceptable in another market, a request for recognition will need to be submitted to FDA. If testing has already been conducted to a past version of a standard that the FDA...
MethodSense Named Top 25 Life Science Technology Vendors

MethodSense Named Top 25 Life Science Technology Vendors

CIO Applications recognizes MethodSense as Top Life Science Technology Vendors Amidst technological innovations, regulatory changes, and increased reliance on patient-centric models, there seems to be a multitude of growth opportunities for life sciences companies. Life sciences undoubtedly remain one of the industries that see rapid technological evolution ahead of them. Even though life sciences has been considered a slow adopter of technology over the years, the future of the industry looks better— with companies adopting new age patient care technologies. Not just that, companies in the life sciences sector today are automating their routine tasks with a vision to invest their time in innovating and creating new business models that are more progressive and patient-centric. From digitizing the way they generate reports to their appointment schedules models and further, post-discharge care, everything is being transformed, which clearly indicates a better future for both—and these companies will need the support of top life science technology vendors. To help these life sciences players partner with trusted technology companies, CIO Applications featured a list of “Top 25 Life Sciences Technology Vendors – 2017.” The list includes the top life science technology vendors that offer groundbreaking solutions to healthcare providers and help streamline their processes. CIO Applications selected MethodSense as a premier consultant in the medical sciences, MethodSense, based in Research Triangle Park, NC. MethodSense helps clients tackle compliance-related challenges. The company also offers InfoStrength—a regulatory compliance information management software—to augment its consulting services and to ensure requirements are met during projects and product development cycles. Rita King, CEO and Senior Regulatory Consultant, explains, “Our platform enables our clients to safely and securely...
FDA Issues New List of 510(k) Exempt Medical Devices

FDA Issues New List of 510(k) Exempt Medical Devices

New Class II 510(k) Exempt Medical Devices As part of the FDA’s movement to decrease regulatory burdens on the medical device industry, the agency published a list of more than 337 Class II product codes of 510(k) exempt medical devices (see the FDA’s Federal Register notice). The FDA has determined that assurance of safety and effectiveness of these devices can be provided by other regulatory controls. By issuing exempt status for these devices, the FDA can redirect resources that would have been spent reviewing these submissions to more significant public health issues. In March of this year, the FDA published a draft of their proposed Class II devices to be exempted in accordance with the 21st Century Cures Act. FDA is now required to publish a list of Class II devices that no longer require premarket notification, also known as 510(k) exempt medical devices, at least once every five years. 93 product codes are now 510(k) exempt subject to partial exemption limitation in addition to general limitations. So, it will be important for manufacturers to confirm if their device is indeed exempt. For example, FDA exempted devices regulated under product code DHB (Radioallergosorbent immunological test system), but they do not believe all products with the product code DHB meet the partial exemption limitation. Therefore, you are still required to file a 510(k) submission if your device falls under product code DHB and is not identified on the list. Pending 510(k) Submissions Medical device manufacturers with pending 510(k) submissions that are now on the list of exempted devices are directed to withdraw their submission. This is great news for these...