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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...
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...
Life Science Cloud Vendor Selection Part 2

Life Science Cloud Vendor Selection Part 2

Technology Strategies to Ensure Benefits and Mitigate Risk Options to Discuss with your Life Science Cloud Vendor Cloud computing is defined to have several deployment models, each of which provides distinct trade-offs which are migrating applications to a cloud environment. NIST defines the cloud deployment models as follows: Private cloud: The cloud infrastructure is operated solely for an organization. It may be managed by the organization or a third party and may exist on premise or off premise. Community cloud: The cloud infrastructure is shared by several organizations and supports a specific community that has shared concerns (e.g. mission, security requirements, policy, and compliance considerations). It may be managed by the organizations or a third party and may exist on premise or off premise. Public cloud: The cloud infrastructure is made available to the general public or a large industry group and is owned by an organization selling cloud services. Hybrid cloud: The cloud infrastructure is a composition of two or more clouds (private, community, or public) that remain unique entities but are bound together by standardized or proprietary technology that enables data and application portability (e g , cloud bursting for load-balancing between clouds). Choosing the correct deployment can depend on who needs to access the service, budget and security concerns. Private clouds are the most secure and most expensive. Private clouds allow companies to have isolated sections of a cloud where you can launch resources in a virtual network. You can have complete control over your virtual networking environment and place your backend systems, such as databases or application servers with no Internet access. You can limit...
Cloud Vendor Selection for Life Sciences

Cloud Vendor Selection for Life Sciences

Benefits and Risks of Moving to the Cloud, Including Cloud Vendor Selection 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...