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.
Tuesday, 07 January 2020
The new year is the perfect time to take stock and set goals for the year ahead. Have you defined your compliance plan for 2020? Without a crystal ball to provide “20/20” vision into the next 12 months, making new year resolutions can help align and focus your efforts and energy in your quest for success. Take tips from IQVIA’s Quality Compliance subject matter experts and consider adopting some of these 20 resolutions to help you fuel your organization’s success in the new decade ahead.
Tuesday, 03 December 2019Jim Erickson, President, Blue Mountain Quality Resources
Equipment and instruments touch every aspect of a product throughout the manufacturing process. These assets are a critical component of determining the quality of the product in each stage of the manufacturing process, from raw ingredients to final form, including packaging and shipping.
In addition, assets are capital intense to purchase and maintain over time. No matter the industry, facilities constantly need to increase the utilization and uptime of their assets in order to drive the highest return on investment. However, for Life Sciences manufacturers in particular, operational compliance is critical, and the risk of non-compliance in this area can completely cancel out the potential for realizing any measurable ROI.
Tuesday, 19 November 2019Phil Johnson, Senior Principal, IQVIA Quality Compliance
Medical Device and In Vitro Diagnostics (IVD) manufacturers have been busy the last few years ensuring that their Quality Management System (QMS) met the requirements of ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP). It was an interesting time as Notified Bodies (NB) and certification bodies also came up to speed on the new requirements and increased level of surveillance on manufacturers. MDSAP introduced new auditing concepts and non-conformance handling, and also introduced a new level of compliance to Quality systems, resulting in a more rounded system for addressing global regulatory needs.
Tuesday, 22 October 2019Caroline Freeman, Principal Consultant, IQVIA Quality Compliance
The MDR affects all medical device
manufacturers that sell to the EU, and its economic impact is already being felt, not just in the cost of implementing the new requirements for new products, but ensuring that legacy products meet the MDR, as there is no grandfathering from the current EU Medical Devices Directive (MDD). Manufacturers of all medical devices above simple Class I will need the services of an MDR designated Notified Body at some time between now and May 2024, with the exact timing being dependent on the validity of existing certificates to the MDD or the Active Implantable Medical Devices Directive (AIMDD).