Medical devices manufacturers are facing unprecedented pressure. The market place is rapidly growing in a highly competitive environment. The medical devices industry needs to be innovative, cost-effective, without compromising quality and reliability, while coping with rigorous compliance and regulations. Medical device companies can also face devastating legal challenges such as patent infringement, product liability, and personal injuries lawsuits.
The current market trends are inducing the industry to a change in its operating model. Traditional lines of business, technology, and competition are blurring; therefore the medical devices will be a convergence of mechanical, physical, and nanotechnology inputs that will be developed and marketed by established and emerging competition.
Besides the regulatory agencies' acceptance of the device's safety and efficacy, the agency must also accept the processes and controls that were in place when the device was designed and developed. Therefore a successful project must take regulatory compliance into consideration right from the start of the project.
Consequently, in order to produce safe, reliable and profitable products in a timely, competitive manner, while staying compliant, the key success factors are:
SoftExpert's system is a flexible framework that allows organizations to ensure that their business processes can follow industry best practice in a manner that is compliant with most international standards and regulations.
SoftExpert comprehensive suite of integrated quality, compliance, process and document management solutions enables your organization to reduce the cost of compliance by automating, improving and effectively manage documents, audits, corrective/preventive actions (CAPA), and other quality and business processes.
SoftExpert can also assist in product reliability and reduce recall costs and exposure by enabling and automating best practices for improved governance in managing the entire product lifecycle, from opportunity identification and prioritization through project execution and closure.
Regulatory agencies have intensified efforts to implement risk management initiatives in product approval processes and inspection processes, and in internal resource management. SoftExpert can help medical device companies comply with risk management requirements with its integrated solution for managing risks and continual improvement policies for governance processes.
Automated workflow and configurable business rules ensure processes enforcement, while enterprise advanced reporting and management dashboard provides reliable information to support decision-making and ensure sustainable compliance.