Tuesday, 14 April 2020Kari Miller, Regulatory and Product Management Leader, IQVIA Quality Compliance
For medical device manufacturers, patient safety is always paramount, but right now, in light of the COVID-19 pandemic, it is definitively top of mind.
As such, implementation of an effective risk management program is critical to helping manufacturers determine the safety of their medical devices throughout the product lifecycle. And while risk management activities are paramount to patient safety, they are also required by regulatory and other quality management standards.
Tuesday, 17 March 2020Lynn Willis, Engagement Manager, Curriculum Development and Product Training, IQVIA
Employees often know little about product liability and the role they have in the company’s overall risk profile. The acts or omissions of even one employee can have severe financial and operational consequences for companies. Risk-based employee training
is essential to bridging the awareness gap.
Since the adoption of ISO 13485:2016, Life Sciences manufacturers have continued to step up their risk-based training requirements. What about your organization? How do you currently define training requirements? If you’re not considering risk as you define them, you will need to add this consideration into your process.
Tuesday, 03 March 2020Roxane Napoli, Director of Marketing Communications, US Marketing, IQVIA
Optimization of your supplier quality management
processes gives you room to differentiate yourself from your competitors and gain advantages in your industry. Optimization alone, however, does not happen without regard for potential risks inherent within complex supply chains or ever-evolving regulatory requirements.
Your organization can distinguish itself from your competitors by circumventing potentially adverse situations before they become realities. Minimizing supplier-related risk will maximize your compliance
improvement activities, thereby growing customer trust and brand loyalty which will ultimately increase your organization’s bottom line.
Tuesday, 18 February 2020Kari Miller, Regulatory and Product Management Leader, IQVIA Quality ComplianceCorrective and Preventive Action (CAPA)
systems provide a wealth of information regarding the quality
of a product or process. However, few companies fully leverage the power of this tool to realize its positive impact to the bottom line.
For instance, it is not uncommon for a CAPA
to be initiated for each product quality-related complaint regardless of scope or severity. Over time, the system becomes laden with records of varying degrees of severity, which are often vetted by issuance order for aging reasons, rather than priority. As a result, the organization cannot optimally allocate resources to correct events that have the most impact on the business as a whole.
Tuesday, 21 January 2020Todd Neal, Product Manager, IQVIA Quality Compliance
For any MedTech company, understanding and supporting a robust and finely tuned internal Quality Management System (QMS)
can be a competitive advantage rather than just a cost of doing business. And it’s imperative. Medical device manufacturers around the globe are required to maintain a Quality Management System to ensure safety and efficacy. Subsequently, they are also required to comply with regulations regarding Design Control for medical devices
to ensure that specific requirements for their devices are met.
Whether an organization is adhering to the FDA and its Quality Systems Regulation (QSR), the European Union and its Medical Device Regulation (EU MDR), or other regulatory authorities and standards for Design Control, it is important to manage the ongoing Quality Management process and provide documented evidence that a well-defined, controlled process is in place and has been properly executed. Under EU MDR, not only must technical documentation be current and demonstrate conformance with requirements, but it must also reflect the development stages applied to the design of the device.