For over 25 years, Peter Muller has worked on software and process improvement projects relating to proofreading with Fortune 500 companies from various industries: Pharmaceutical, Medical Device & Consumer Goods. He has a wealth of experience working with international clients to define their organization’s goals and help them leverage new technologies to achieve productivity gains, process improvements and cost savings.
How are increased compliance requirements impacting medical devices?
How are increased compliance requirements impacting medical devices? Discover the Future of Medical Device Regulation.
We will dive into the rapid growth of the medical device sector, driven by cutting-edge technologies and rising regulatory requirements.
Rising regulatory demands: are medical device suppliers ready?
The global medical devices market is set to reach $886.80 billion in value by 2032 . As devices become more critical to patient outcomes, regulators’ quality and safety expectations and associated controls are increasing.
Soaring Medical Device Scrutiny: How is the Market Adapting?
In the light of new research, Peter Muller and Mike Baird of Schlafender Hase assess how well Class 2 and 3 device manufacturers in Europe and the US are adapting to a rise in regulatory controls. Published in MedTech Intelligence The global medical devices market is expected to grow from $542.21 billion in 2024 to $886.80 billion by 2032[1]. As devices become more critical to patient outcomes, regulators around the world are increasing their controls around their manufacturing, distribution, and monitoring – bringing suppliers of these products more closely into line with requirements around pharmaceutical goods. New research[2] has assessed how well manufacturers and their regional or national partners are adapting to the rising regulatory demands. The 2024 study, with 202 regulatory professionals at Class 2 and 3 medical device companies in the EU (Germany) and North America (the US), highlights the number of challenges currently vying for attention and investment and assesses device companies’ current state of regulatory readiness. Medical devices: the rise of regulatory requirements The study started by surveying medical device suppliers’ involvement with a number of regulatory initiatives. E-labeling/eIFU Currently, just under two-thirds (62%) of medical device companies are involved in e-labeling initiatives, and up to a third of these (30%) are ‘very’ involved. EU companies are more likely to be actively involved in e-labeling than those in the US (71% vs 53%). This makes sense as the EU is ahead of the US with the practice; companies here are also less likely to outsource labeling as a service. FHIR/standardized data exchange Fast Healthcare Interoperability Resources (FHIR) is a proposed global standard, designed to streamline data exchange and facilitate real-time information access for healthcare providers. It will make many regulatory professionals’ lives easier by shifting the emphasis of content creation and management to ‘publishing’ rather than ‘printing’, helping to drive process digitization in the production and management of regulated medical device information and content. In the survey, three in five respondents (60%) claimed to be involved with the standard, rising to 67% for EU (German) respondents; in the US, only just over half were occupied with FHIR (FHIR is not as high profile in the US, though the FDA is encouraging manufacturers to adopt interoperability standards). UDI/device identification Unique device identification (UDI) makes it possible to track individual devices across the healthcare supply chain internationally. In the survey, two-thirds (66%) of respondents (rising to 74% of EU survey participants, but accounting for a much lower proportion in the US at 57%) express involvement in UDI activity. Anti-counterfeiting Taking proactive measures to mitigate the threat to product quality and patient safety posed by counterfeit products is a further expectation and robust product identification and traceability are a cornerstone of this practice, along with vigilant supply chain monitoring. In the survey, over half (55%) of respondents indicate at least some involvement with anti-counterfeiting. Navigating regulatory demands Medical device companies are dealing with the impact of increasing regulations in a number of ways, including the implementation of key standards (e.g. ISO);
Regulatory authorities are approaching AI with understandable caution, recognizing its obvious opportunities as well as its inherent challenges. Workshops, workplans, input and industry collaboration are high on the agenda.
How TVT helps the Top 5 Functions of Regulatory Professionals
The challenges faced by regulatory professionals are substantial. New products must be brought to market quickly and the pressure is on to turn projects around faster. Furthermore, regulations are constantly evolving, which means labeling and packaging must be updated.
Off Label Marketing: How to Avoid False Claims in Pharma
The risk is high, whichever side of the coin you look at. Off-label marketing and other off-label promotion have led to some of the largest legal settlements in the pharmaceutical industry – up to $3 billion in one case
Tank Worldwide Case Study – Fast, focused quality control in advertising
The creative content from Tank WW includes text copy, videos, websites or micro-sites, email promotional material, PowerPoint presentations, and more. A proofreading team provides the quality control for advertising material to ensure accuracy, consistency and compliance across content and different media.
Best Practices for your Promotional Review Process
The aim of a pharmaceutical promotional review process is to ensure the accuracy and compliance of promotional material with the relevant medical, legal, and regulatory aspects of a specific market.
Medical writing describes a wide range of writing in the fields of medicine and healthcare. Discover more about medical writing and “a day in the life.”
Introducing TVT 12: A New Era in Compliance and Efficiency
With growing demands on regulatory professionals to ensure accuracy and efficiency, the newest version of the industry-trusted proofreading software, TVT 12 delivers enhancements that allow users to navigate complex document requirements with greater ease and confidence.
Introducing TVT 12: A New Era in Compliance and Efficiency
With growing demands on regulatory professionals to ensure accuracy and efficiency, the newest version of the industry-trusted proofreading software, TVT 12 delivers enhancements that allow users to navigate complex document requirements with greater ease and confidence.
The Game-Changing Features of TVT 12: A New Era in Compliance and Efficiency
TVT 12 is here!
This annual update is packed exclusively with new features and improvements from customer requests that support key industry initiatives, boost efficiency, and add even more speed and detail to your document reviews.
The Game-Changing Features of TVT 12: A New Era in Compliance and Efficiency
TVT 12 is here!
This annual update is packed exclusively with new features and improvements from customer requests that support key industry initiatives, boost efficiency, and add even more speed and detail to your document reviews.
