In a highly competitive market, like the medical device market, compliance, time-to-market, and continual improvement are instrumental.
Fremont, CA: Beginning from design to post-market, administering change to the device is vital. A minor process deviation or transition to a component can lead to significant problems like product quality issues, data loss, patient safety, and probably regulatory actions or recalls. The medical device divisions of the companies help customers introduce their products in the market faster, track their products in the field, and manage post-market surveillance while addressing a variety of regulatory issues in the medical device industry.
Regulatory Compliance Strategy and Execution
Whether it is a large global medical device manufacturer or a small startup, new to the regulatory landscape, a top-to-bottom risk management strategy to safeguard resources are aligned, the benefit is maximized, and regulatory exposure is minimized.
IT Strategy, Roadmap, and Implementation
Building an IT roadmap, which lays the company’s strategy and governs how technology will back the business growth over the coming 3-5 years, is essential. Expertise in IT helps in accelerating many medical device manufacturers to deploy data, technology, applications, and capabilities that drive innovation.
Medical device manufacturers have always been inclined to using cloud technologies in regulated areas and purge from costly on-premise solutions that do not meet their business needs anymore. Still, compliance has always been a reason for concern. It is also crucial to single out the right cloud vendor to meet the business needs and achieve and maintain continuous GxP cloud compliance without any issue.
UDI Strategy and Implementation
Ensuring that the company is submitting its UDI to the regulatory agencies, including a complete assessment of supply chain and regulatory activities, process improvements, inventory of medical devices, and overall readiness, is very important.
EU MDR/IVDR Strategy and Implementation
Adoption of managed services and project-based solutions can help plan, manage, and execute any or all the activities enterprise-wide, which are needed to meet the Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) requirements.
Digital transformation is turning to be the backbone of every industry that helps life sciences customers to get products to market faster, reduce IT spend and footprint, and enable compliant digital transformation.