Caroline Freeman, Senior Consultant, Quality & Compliance Services, IQVIA With less than 2 months to go to the date of application of the EU Medical Devices Regulation 2017/745 (MDR), set for May 26, 2020, the Commission finally announced on March 25, 20201 that work is ongoing to postpone this by one year. The announcement was quickly followed by the publication of the Commission proposal text on April 3, 20202, and this was followed within three working days by the Council’s own document establishing the mandate for negotiating with the European Parliament, and also, incidentally, making ..read more

Kari 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. Regulatory Requirements These requiremen ..read more

Davor Milosevic, Quality Assurance Manager, IQVIA Quality Compliance With data being one of the most valuable assets that an organization owns, information security management is an essential business practice. Protection of confidential data, particularly personal data with the introduction of GDPR in 2018, is critical for compliance and a business’ trust and reputation. As highly risk-averse as the Life Sciences industry is, it is safe to say that most Life Sciences organizations will have some form of controls in place to manage information security. However, the degree of information prote ..read more

The new year is the perfect time to take stock and set goals for the year ahead. Have you defined your 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. As a Quality professional, I resolve to: Focus on Quality first, knowing Compliance will follow. – Kari Miller, Regula ..read more

Ian Elius, Associate Client Relationship Director, Cloud and Customer Success, IQVIA Quality Compliance Customer success, particularly in the Life Sciences, depends on developing a collaborative partnership between technology solutions providers and their customers. Many times, this partnership experiences challenges, especially when the responsibilities of both parties are not clearly communicated and understood. This blog examines the areas the customer can focus on to increase the probability of success for the overall partnership and specific engagements. As a customer, focusing on and mak ..read more

Phil 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 sys ..read more

Todd 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 to ensure that specific requirements for their devices are met. Whether an organization is adhering to the FDA a ..read more

Caroline 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 ..read more

IQVIA Quality Compliance EU MDR readiness isn’t just a single activity – and is not isolated to a company’s activities in the EU. It requires changes to processes across your organization. As you prep for the looming EU MDR 2020 compliance deadlines, are you ready? These previously published blogs provide insight into the components of the medical device product lifecycle, from concept to market, that you need to consider in assessing your organization’s preparedness for the May 2020 deadline. EU MDR: The Clock is Ticking…Are You Equipped? Are you prepared for the implementation of EU MDR, o ..read more

Kari Miller, Regulatory and Product Management Leader, IQVIA Quality Compliance When implementing enterprise software, whether a Regulatory Information Management (RIM) solution, Quality Management System (QMS) or an ERP system, the greatest predictor of its success will be how an organization manages the psychology of change. When an organization decides to implement new processes and/or new solutions, there are four phases of change that the organization is likely to experience: Denial (resistance), confusion, renewal and contentment. Hopefully the organization will experience all four phase ..read more