New Whitepaper Advances A Structured Approach To Medical Device Development
Medical device development is a complicated and heavily-regulated industry which carries an inherent possibility of costly, and potentially life-threatening, errors in data, if that data is not recorded using a consistent and systematic approach.
And that’s where a structured approach can add another layer of certainty, security, and cost-saving for medical device and pharmaceutical product development teams. But what exactly is a structured approach, and how can it help product development?
In our latest whitepaper – “Why Medical Device Companies Choose Compass for a Structured Approach to Product Development” – we explore the benefits of taking a more structured approach to medical device development, citing and advocating four key areas that can help your business safely expedite your next product to market.
What is a structured approach?
A structured approach to medical device development, and the associated regulatory compliance, means the creation of an environment which guides users through required tasks systematically, and consistently. In essence, it ensures a common approach that reduces the likelihood of errors and accelerates the time to market. So what are those four core components?
When data is compliant with a given data model, and organized in a standard format with a clearly defined structure, it becomes immediately more usable, accessible, and accurate for the people and software counting on it.
In contrast, unstructured data is disorganized, duplicated in many places and does not conform to a database structure, it cannot be easily leveraged by other software because it does not follow standardized rules or formatting.
Reusability is a key driver in reducing the time needed for a medical device to be designed and gain the appropriate approvals to be brought to market. But copying and pasting between spreadsheets and other documents increases the chance of human error.
In our whitepaper, we explore the potential of preconfigured templates, specific to medical device development and different global markets, to enable device development to be documented in a submission-ready format.
Integrated Risk Management
When you’re developing a new medical device, one of the main challenges is to ensure that it meets safety regulations and standards set by your intended global markets. Particularly for medical devices, an omission or error can literally be the difference between life and death. Risk analysis and management is imperative to ensure your device does not impose any harm to its users.
So how can you fully integrate risk management processes and address multiple regulatory standards within the design control process, without slowing development or compromising on safety?
When a change has the potential to impact dependent relationships, those relationships can be easily identified for resolution. Trace matrices adhere to an organization’s standard operating procedures and can be used for reporting.
With a database, you have a single source of truth for every item of data. So if a change is made there, every other document or location where that item is referenced is automatically updated. Automated processes make it easy to apply quality best practices across a product’s development lifecycle, and provide powerful traceability.
A structured approach to medical device development
Taking a structured approach to compliance, our solutions enable medical device and pharmaceutical product development teams to guide users systematically and consistently through robust processes. This ensures a common approach to product development, design control, reporting, and the submission of compliance documentation.
Compass is a pre-configured, out-of-the-box, SaaS solution purpose-built to connect data across all functional areas of medical device product development. It’s best suited for small- to medium-sized medical device companies looking for guidance on how to bring their products to market with less risk.
Interested to find out why five out of the top six medical device companies choose Compass for a structured approach to product development?
Read our latest whitepaper – “Why Medical Device Companies Choose Compass for a Structured Approach to Product Development”