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Implement 21 CFR Part 820 Controls Early On

Implement 21 CFR Part 820 Controls Early On

Benefits and Risks of Moving to the Cloud Migrating to the Cloud: What are the Benefits? According to the National Institute of Standards and Technology, the cloud is “a model for enabling convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal management effort or service provider interaction.” Most companies’ IT infrastructure use less than 30% of their capacity. It took years to get the capacity to where it is today, and it takes months to increase capacity. Employing qualified resources to maintain such an infrastructure is difficult and expensive. Cloud providers utilize about 65% of their capacity and can add capacity quickly. In short, cloud providers benefit from economies of scale, which enables them to lower individual usage costs and centralize infrastructure costs. Companies benefit by only paying for what they consume. Companies can increase or decrease their usage rapidly, and can spend less time managing complex IT resources. Not only do efficiency improvements reduce costs, the nature of some costs can change from being capital investment in hardware and infrastructure (CapEx) to a pay-as-you go (OpEx) model. Maximizing IT capacity utilization, improving IT flexibility and responsiveness, and minimizing cost are not the only advantages of the cloud. Collaboration can be one of the most important advantages of cloud computing. Multiple users, from around the world, can collaborate more easily on documents and projects. Because the information is hosted in the cloud, and not on individual computers, business owners can collaborate with external stakeholders in a secure environment with nothing...
21 CFR Part 820 Ensures Your Device is Safe and Effective

21 CFR Part 820 Ensures Your Device is Safe and Effective

An Early Practical Handle on 21 CFR Part 820 Improves Your Medical Device Business Operations The purpose of regulatory affairs is to ensure that your company complies with applicable laws and regulations. These regulations, such as Quality System Regulation 21 CFR Part 820, are intended to ensure devices entering the marketplace are safe and effective. What is the Quality System Regulation? FDA has identified in the Quality System (QS) regulation the essential elements that a quality system must embody, without prescribing specific ways to establish them. Because the QS regulation covers a broad spectrum of devices, production processes, etc., it allows some leeway for medical device manufacturers to determine the necessity for, or extent of, some quality elements and to develop and implement specific procedures tailored to their particular processes and devices. If you don’t fully understand 21 CFR Part 820 and how to apply it properly to your company, find a medical device regulatory consultant who does. Having experience in this area is critical to efficiently implementing compliance that supports your business goals. Quality System Regulation 21 CFR Part 820 focuses on current good manufacturing processes (cGMP) and controls used for the design, packaging, labeling, storage, installation and servicing for all finished devices intended for human use. You should know that 21 CFR Part 820: Is an FDA-mandated system of product design Requires you to document the evolution of the life of your product Applies a market-first product development focus Requires a team-oriented approach to product commercialization As a process, tends to challenge product design to the point of improvement Compliance is a necessary expense; don’t put yourself in a...
Meet FDA Requirements

Meet FDA Requirements

Meet FDA Requirements for Medical Device Company Compliance Most medical device executives know they need FDA clearance to legally market and promote their product in the U.S. Beyond FDA approval, understanding how to effectively commercialize a medical device product means adapting to industry and legal expectations for operating as a medical device company. These expectations ensure that you deliver safe and effective products. Knowledge and experience is required to do this effectively and to avoid costly mistakes. At this point, it’s important to realize that although we talk about the FDA as a regulatory body, it is, in fact, a law enforcement agency with the powers associated with such authorities. The FDA can cite, fine and prosecute for violations of laws, such as 21 CFR Part 820 or 21 CFR Part 11. The laws the FDA enforces are administrative laws that are part of a national regulatory scheme, like police law and international trade. Medical device companies not compliant with 21 CFR Part 820, and other applicable regulations, make themselves vulnerable to FDA enforcement practices. The tricky part is that the FDA doesn’t tell you how to operate as a compliant company. You have the flexibility to implement the necessary processes to satisfy the applicable regulations and support them with your own compliance practices. However, you’re expected to fully understand the intent of the regulations and meet those expectations—regardless of your size and resources. While FDA enforcement actions rarely result in jail time for executives, they can force expensive corrections and cause significant damage to your reputation. Truly, it’s best to comply to FDA requirements willingly and...
How to Structure a New Medical Device Business

How to Structure a New Medical Device Business

There’s More to Being a Medical Device Business than IP and R&D An emerging medical device business tends to focus their energy on product development and R&D. This is understandable because medical device founders are often first experienced innovators. As innovators, there’s a natural affinity to maintain a continued focus on product development and maturation. Having a clear IP position and strategy is an important factor for attracting capital, which could further emphasize the importance of R&D, product development and market analysis. Nevertheless, being and growing as a viable medical device business catering to the U.S. market requires much more than R&D, positioning your IP and measuring how big your market is. It involves developing an operational framework that structures your organization as a medical device company (Figure 1) and enables the commercialization of your product. Some Medical Device Business Requirements: Regulatory Affairs Risk Assessment and Risk Management found in FDA Guidances and ISO 14971 Compliance to IEC 62304 to manage software risks Quality Management Design Controls that are included in FDA 21 CFR Part 820 QMS requirements you might find in Part 820 and ISO 13485 FDA 21 CFR Part 11, if your device incorporates software Safety Complying with IEC 60601-1 3rd Edition and its collateral standards Clinical data or a clinical trial When wrestling with regulatory, quality and safety issues, executives fresh to the medical device industry often take uncertain or delayed steps as they navigate the path to becoming a medical device company. The biggest mistakes we see emerging medical device business executives make include delaying the development of their regulatory strategy and their quality system, which...