Latest From Cetas Healthcare

KOLs Drive Innovation & Adoption in Medical Devices

Introduction: Key Opinion Leaders (KOLs) play a crucial role in the medical device industry. Their expertise, influence, and ability to bridge the gap between innovation and clinical practice make them invaluable in driving both the

MedTech devices
Over my 13 years as a regulatory professional, I've seen firsthand just how crucial Post-Market Surveillance (PMS) plans are, especially for specialized MedTech devices like those in orthopaedics.
The Transformative Impact of Artificial Intelligence (AI) on Diagnostics
Artificial Intelligence (AI) has emerged as a game-changer in the field of diagnostics, offering unprecedented advancements in accuracy, efficiency, and accessibility.
Adapting to Global Regulatory Changes in Orthopaedic Device Manufacturing

Introduction: As regulations become more stringent, MedTech manufacturers must adapt to ensure compliance while continuing to innovate. Most orthopaedic devices fall under regulations driven by an increasing demand for safer, more effective medical device testing.

Elevating Device Safety Advanced Clinical Survey Strategies
The journey of a medical device extends far beyond its launch. And post-market clinical surveys emerge as a pivotal tool, not only in sustaining the lifecycle of medical devices but also enhancing their safety, efficacy,
Cardiovascular Care: A MedTech Market Research Perspective

Introduction: Cardiovascular care is advancing rapidly, driven by innovations that aim to transform patient experiences and outcomes. At the forefront of this transformation are the detailed patient journeys—from the first signs of symptoms to long-term

Qualitative insights and Market analysis - MedTech

Introduction: “How likely is it that you would recommend our company/product/service to a friend or colleague?” One simple question that provides a clear line of sight into the company’s customer relationship landscape. The strengths are

EU Medical Device Regulation (MDR) Insights for MedTech

Introduction: As we navigate through critical regulatory milestones in the medical device industry, it is essential for manufacturers to fully understand the impact and requirements of the EU Medical Device Regulation (MDR). With pivotal compliance

Customer Segmentation is Vital for Medical Device Manufacturers

Introduction: In the intricate realm of medical device manufacturing, success hinges upon a deep understanding of the diverse needs and preferences of healthcare professionals, institutions, and end-users. Customer segmentation emerges as a critical tool in

Market Research Studies for Medical Device

Introduction: In the dynamic and rigorously regulated medical device industry, the introduction of a new product demands not only strategic foresight but also robust execution, underpinned by a thorough understanding of market needs, customer expectations,

MedTech Market - Medical Technology

Introduction: In a crowded MedTech marketplace, how do you stand out? While each brand is contesting for the attention and trust of customers, including healthcare providers, patients, and purchasing decision-makers – how do you communicate

Medical Devices – MedTech Market

Introduction: Once upon a time, MedTech companies could afford to be sales driven organizations on the back of their engineering prowess. Alas, those days are now over. MedTech companies face a consistent challenge of distinguishing

European Medical Device Regulation (EU MDR 745/2017)

Introduction: The European Medical Device Regulation (EU MDR 745/2017) has significantly enhanced the regulatory framework governing medical devices in the European Union (EU). Among its many provisions, incident reporting stands out as a crucial aspect

MedTech Market Research Methodology

Introduction: In the ever-evolving landscape of healthcare technology, new product development and commercialization of Medical Devices can be a daunting task. One of the greatest challenges faced by product management and marketing leaders in the

MedTech devices and diagnostics

Introduction: The MedTech industry has evolved significantly over the years, with innovations driving the development of life-saving devices and diagnostics. In this era of precision medicine and evidence-based healthcare, the demand for robust data to

Diagnostic (IVD) devices - post-market surveillance (PMS)

Introduction: In vitro diagnostic (IVD) devices play a pivotal role in healthcare, aiding in the diagnosis, monitoring, and management of diseases. With the continuous advancement of technology and an ever-expanding IVD market, ensuring the safety

Clinical Surveys for Monitoring Medical Device

Introduction: Long-term clinical data is essential for understanding the performance, safety, and overall effectiveness of medical devices over an extended period. Some key reasons why Long-term data is important for medical devices: 1. Detecting Long-Term

MedTech Market Signals

Introduction: Brand tracking is a systematic process to evaluate the health of a brand over time. It’s an ongoing assessment that measures the consumer perception of a brand, typically conducted one or two times a

Post-Market Clinical Follow-up (PMCF) Surveys for Medical Devices

Introduction: Post-Market Clinical Follow-up (PMCF) surveys have become a vital tool for ongoing assessment and validation of device performance and safety. The integration of ISO 14155 guidelines into PMCF activities offers regulatory professionals a robust

Post-Market Clinical Follow-up (PMCF) surveys - medical devices

Introduction: A well-designed questionnaire is one of the most critical aspects in the execution of Post-Market Clinical Follow-up (PMCF) surveys. These surveys ensure that your medical devices continue to perform as intended and remain safe

Market research, MedTech and Artificial Intelligence (AI) in Healthcare

Introduction: The healthcare industry is rapidly evolving and one of the key drivers of this transformation is Artificial Intelligence (AI). To stay competitive, MedTech firms must stay ahead of the curve in AI adoption with

Clinical Evaluation Report (CER) medical devices

Introduction: In the dynamic arena of medical device regulation, clinical evaluations play a pivotal role in assessing the medical devices’ safety, performance, and effectiveness. A crucial component of a comprehensive Clinical Evaluation Report (CER) is

Dental Market - Artificial Intelligence: Revolutionizing Diagnostics

Welcome to the dawn of 2023’s dentistry future, where revolutionary trends are reshaping the industry. This year, the dental sector is undergoing a profound transformation fueled by technology and evolving patient preferences. Here are the

MedTech Marketing Research methodology - Medical devices

Concept testing is a fundamental Marketing Research methodologyprimarily used to assess customer feedback onnew product/service ideas or concepts. It is a great evaluation tool to determine whether a company should move forward with a product

Post-Market Clinical Follow-Up (PMCF) medical devices

Introduction: In the dynamic space of the medical devices world, ensuring their safety and effectiveness post-market is paramount. Post-Market Clinical Follow-Up (PMCF) studies play a pivotal role in this endeavor. Among the various PMCF approaches,

post-marketing surveillance (PMS) medical device

Explore Clinical & Regulatory Services Introduction: The convergence of proactive and reactive methodologies within a post-marketing surveillance (PMS) system can significantly enhance the effectiveness and robustness of medical device monitoring. By harmonizing these approaches, manufacturers

European Union Medical Device Regulation (EUMDR) and Vitro Diagnostic Medical Devices Regulation (IVDR)

Introduction: ‘Sufficient clinical data’ is a critical term used in the context of medical device regulations to describe the level of evidence required to demonstrate the safety and performance of a medical device. It refers

EU Medical Device Regulation (MDR), Therapeutic Goods Administration (TGA), Medical Devices Bureau (MDB), Pharmaceuticals and Medical Devices Agency (PMDA), Federal Office of Public Health (FOPH), International Medical Device Regulators Forum (IMDRF), Brazilian Health Regulatory Agency (ANVISA), National Medical Products Administration (NMPA) and Central Drugs Standard Control Organization (CDSCO)

Introduction: The EU Medical Device Regulation (MDR) is a set of regulations that govern the safety and performance of medical devices in the European Union. The MDR is one of the strictest medical device regulations

Doctors wearing VR simulation with hologram medical technology

Medtech companies are expected to play a key role in the digital transformation of healthcare. Many are already prioritizing building digital capabilities in-house via investing in R&D, business models, and acquiring assets to expand their

PMPF Surveys for IVD Products

Introduction: As the regulatory environment progresses, ensuring the safety, performance, and compliance of In Vitro Diagnostic (IVD) products is of paramount importance. One key aspect of post-market surveillance is conducting Post-Market Performance Follow-up (PMPF) surveys.

Medical Devices in Europe under the EU MDR 2017/745

Introduction: The European Union Medical Device Regulation 2017/745 (EU MDR) has brought significant changes to the regulatory landscape for medical devices in Europe. Conformity assessment plays a crucial role in ensuring the safety and performance

Post-Market Clinical Follow-up (PMCF) - Medical Devices

In the rapidly evolving landscape of medical devices, ensuring patient safety and product effectiveness is of paramount importance. Post-Market Clinical Follow-up (PMCF) surveys have emerged as a powerful tool for gathering real-world data and insights,

Market Research and Regulatory Considerations Drive Informed Decisions for Medical Device

The fusion of market research and regulatory considerations can provide valuable insights and help medical device manufacturers make informed decisions when choosing a market for their product launch. Here’s how the combination of these two

Market Research, MedTech Product, Clinical and Regulatory Services

MedTech product managers often use Customer Insights or Voice-of-Customer analysis to gain market insights and make evidence-based decisions for their New Product Development (NPD) activities or new product launches. We regularly collaborate with numerous MedTech

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