September 2010 Posts

Proposal to Delay EU MDR Implementation Brings Manufacturers Some Good News

Proposal to Delay EU MDR Implementation Brings Manufacturers Some Good News

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 a much-needed technical correction to the original Commission proposal3. Political agreement from the European Parliament (EP) was reached in a vote in plenary session by an overwhelming majority of EP members, on April 16, 2020. The EP dealt with the proposal as an urgent procedure and made no additional changes to the Council’s text. (more…)

Reduce Product Risk, Improve Patient Safety

Reduce Product Risk, Improve Patient Safety

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. (more…)

Limit the Stakes with Risk-Based Employee Training

Limit the Stakes with Risk-Based Employee Training

Lynn 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. (more…)

Distinguish Your Organization with Risk-based Supplier Inspections

Distinguish Your Organization with Risk-based Supplier Inspections

Roxane 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 and quality improvement activities, thereby growing customer trust and brand loyalty which will ultimately increase your organization’s bottom line. (more…)

Quantify Risk to Boost CAPA Efficiency

Quantify Risk to Boost CAPA Efficiency

Kari Miller, Regulatory and Product Management Leader, IQVIA Quality Compliance

Corrective 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. (more…)

ISO/IEC 27001 and the Value of Certified Life Sciences Services Providers

ISO/IEC 27001 and the Value of Certified Life Sciences Services Providers

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 protection and the delivery of real benefits to the market are incumbent on the effectiveness by which these controls are organized and monitored. ISO 27001 certification is the gold standard in demonstrating that effectiveness. (more…)

Quality Management and Design Control Requirements for MedTech

Quality Management and Design Control Requirements for MedTech

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 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. (more…)

20 Quality Compliance Resolutions for 2020

20 Quality Compliance Resolutions for 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. (more…)

A Guide to Success with Technology Solutions

A Guide to Success with Technology Solutions

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. (more…)

Managing Compliance Risk with Integrated Asset Management Software

Managing Compliance Risk with Integrated Asset Management Software

Jim 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. (more…)