Compliance is a term you’ve undoubtedly heard of in the medical field. New technology in medicine must conform to regulations and standards in the industry. Medical device compliance is multi-faceted and can require expertise from an outside source. For many organizations, relying on an expert may be necessary to bring products to market quickly while remaining cost-efficient.
What is Medical Device Compliance?
Medical device compliance has many aspects and can quickly become complicated. But in general terms, compliance ensures that processes and procedures meet the required industry standards and regulations for a device. Compliance also involves describing the company’s practice for executing any processes and ensuring that employees are trained to follow said processes.
When trying to ensure compliance, medical device manufacturers must be aware of the regulations that apply to the device in question. This is not always an easy task because these regulations vary depending on the intended market for the device. Regulations can also vary at the national and international levels, presenting more complications for manufacturers.
Solving Medical Device Compliance Issues
Before you can begin solving medical device compliance issues, you’ll need to know if you have the resources to do so. A lack of staff, expertise, time, or money may prevent an organization from moving quickly to solve compliance issues. Having the proper resources in place to evaluate compliance leads to important information that will affect the product.
Committing the proper resources can translate the data you gather at this stage into many necessary pieces of information. This information includes company governing procedures, device design requirements and specifications, and manufacturing requirements and processes. All of these will drastically alter your product, so contributing resources to discover compliance issues is critical.
There is also the issue of varying compliance requirements. Some of the most difficult compliance problems to navigate for device makers are the updated EU MDR requirements and many non-US country regulations. For medical devices made with hopes for worldwide distribution, these regulations increase the rigor required to obtain approval before doing so. This compliance issue can cause serious impediments–requiring time and money as organizations attempt to bring a product to market.
But perhaps one of the most challenging aspects of compliance is maintaining regulations throughout a product’s lifespan.
Keeping Compliance Across a Product’s Lifespan
Maintaining medical device compliance across the lifespan of a product can seem impossible. After a product has been brought to market, compliance shifts towards post-market activities. These post-market activities include additional surveillance activities, reportability activities, compliance maintenance from the manufacturer, and investigation into customer feedback.
Any organization that doesn’t meet shifts in compliance can quickly find themselves in a bind. Without the proper knowledge of shifting regulations, medical devices that were once a valuable asset can quickly become a drain on time and money.
Keeping compliance can seem impossible without a team dedicated to it. Minnetronix functions as a partner for Full Lifecycle Solutions, including the compliance stage in medical device development. Our skilled teams use a wealth of clinical experience to clear a path to regulatory approval and bring products to fruition. For more information on what Minnetronix can do for your organization, contact us today and accelerate your next breakthrough.