Strategic Alignment of Quality Management Through Leadership Collaboration
17 Dezember 2024
Annika Lörtscher
129
In today’s fast-paced business environment, companies in the medical device industry face the critical challenge of balancing regulatory compliance with operational efficiency. Regulatory requirements, such as implementing a quality management system (QMS), are not merely checkboxes to tick – they...
Risk Management as a Shared Responsibility: Bridging Expertise in Medical Devices and Finance
12 Dezember 2024
Annika Lörtscher
218
Risk management for medical devices operates within a highly specific and regulated framework, guided by the MDR/IVDR and the ISO 14971 standard. This makes it distinct from the broader scope of financial risk management undertaken by a CFO. Despite these differences, there are intriguing...
AI and Regulation: Navigating the Future of Governance
11 Dezember 2024
Annika Lörtscher
187
As Artificial Intelligence (AI) continues to advance rapidly across industries, its integration into regulatory frameworks and the development of new regulations to address its implications are becoming increasingly significant. AI has the potential to transform the way products and services are...
The Art of Global Registration Projects: A Focus on Teamwork, Communication, and Planning
10 Dezember 2024
Annika Lörtscher
202
Global registration * projects are complex undertakings that demand not only regulatory expertise but also excellent planning, organisation and teamwork. Without careful management, these projects can become challenging to navigate and may quickly spiral into inefficiency. In a dynamic environment...
Managing Complexity by Embracing Change – A Conversation Across Disciplines
6 Dezember 2024
Annika Lörtscher
226
In the fast-evolving MedTech world, all experts face the shared challenge of adapting to rapid technological advancements while navigating stringent regulations. Within this dynamic environment, professionals from different subfields – such as software engineers and regulatory specialists – bring...
Ensuring Safety & Effectiveness Through Collaboration, Simplification and Superpowers
5 Dezember 2024
Annika Lörtscher
229
At ISS AG, collaboration isn’t just a buzzword – It’s the backbone of our work. Efficient collaboration between medical writing and risk management is crucial to ensure patient safety and performance of medical devices and IVDs. Our integrated approach combines expertise across disciplines...
Leveraging Clinical Data Under the MDR and IVDR – It Doesn’t Require Superpowers, Just Hard (Team)Work and Smart Planning
4 Dezember 2024
Annika Lörtscher
295
At ISS, we bring the integrated approach to life by ensuring that our teams work seamlessly together, particularly where their expertise and fields overlap. It’s through this collaboration that the "magic" happens – transforming joint efforts into tangible value and results when leveraging...
Clinical Investigation Approval Submissions
28 November 2024
Julie Tantau, AuD
245
Determine Health Authority (HA) and Ethics Committee (EC) requirements early for a smooth submission. Submitting the dossier to the HA and EC is an accomplishment and milestone within the clinical investigation process. For many, this can be a chaotic undertaking accompanied by uncertainty, but it...
Clinical Investigations - Do not underestimate the initial phase
7 November 2024
Julie Tantau, AuD
413
Once you have completed your technical file, which includes a very detailed clinical evaluation plan, it feels as though you have reached the peak of a mountain. Now, you know what clinical data you need to collect and what endpoints to test. Great, but don’t stop for too long to take in the view...
Verwaltungsverfahren in der Schweiz: Medizinprodukte im Fokus
16 Oktober 2024
Bernhard Bichsel
204
Hersteller und andere Wirtschaftsakteure von Medizinprodukten, die auf dem Schweizer Markt tätig sind, müssen sich an eine Vielzahl von Vorschriften halten. Swissmedic, die zentrale schweizerische Aufsichtsbehörde für Heilmittel, ist verantwortlich für die Durchsetzung dieser Vorschriften und...
Essential Considerations for Systematic Literature Searches in IVD Performance Evaluations
13 September 2024
Kathrin Abegg, DVM PhD, Anna Neodo, PhD
509
The IVDR requires manufacturers to conduct and document a systematic literature search as an integral part of the performance evaluation. However, literature searches for IVDs often present more challenges than searches for other devices. Here, we highlight the key points to consider when...
Navigating Compliance: Chinese Standards for Medical Electrical Equipment
30 August 2024
Annika Lörtscher
654
One of the steps in the approval process for medical devices in China is ensuring compliance with Chinese electrical safety standards and passing local tests. If not thoroughly understood, these requirements can pose significant challenges and may consume considerable time and effort. Although the...
Software Failure Probability: Key to IEC 62304 Safety Classification
7 August 2024
Valentin Chapuis
698
Software (SW) products play an increasingly important role in the medical device field, and managing SW-related risks is paramount. IEC 62304:2006/A1:2015 represents (amongst other standards, incl. IEC 82304-1) the current state-of-the-art manufacturers should respect to ensure compliant SW...
Relevance of state of the art (SOTA) considerations for product development
11 Juni 2024
Kathrin Abegg, DVM PhD
1195
Establishing the generally acknowledged state of the art is a key aspect of the clinical evaluation process for any medical device. Even though the MDR does not define what the state of the art encompasses or provide guidance on the methodology for its establishment, it is evident that state of...
The European Artificial Intelligence Act and its challenges at the intersection of innovation and regulation
14 Mai 2024
Samuel Kilchenmann, PhD
1150
Artificial intelligence is poised to transform healthcare by expediting the digitalisation of medical devices. Predictions say the use of AI in medical devices is anticipated to proliferate worldwide in the coming years, while regulatory-wise, the world's attention has also been focused on the...
In-house IVD manufacturers, is your QMS IVDR ready?
8 Mai 2024
Valentin Chapuis
1128
In-house IVDs (also referred to as Laboratory Developed Tests, LDTs) manufactured and used within a single health institution are regulated products under the IVDR. While a CE mark is still not necessary, in-house IVD manufacturers are required to establish an “appropriate” Quality Management...
The presumed burden of post-market clinical data
17 April 2024
Julie Tantau, AuD
1161
As everyone is now aware, post-market clinical evidence for medical devices sold in Europe must be regularly collected and assessed. The EU Medical Device Regulation 2017/745 (MDR) demands an increased level of scrutiny of medical devices by notified bodies to guarantee their safety and...
Intended purpose: The compass of your market strategy
11 April 2024
Karin Ackema, PhD
1234
When bringing a medical device to the market, the definition of its intended purpose is paramount. But what makes this intended purpose, also known as intended use, so vital for your business? Just as a compass helps travellers find their way, the intended purpose of a medical device directs...
Clinical evaluation routes with limited clinical evidence
3 April 2024
Kathrin Abegg, DVM PhD
1335
The Medical Device Regulation (MDR) has heightened the standards for clinical evidence, yet ambiguities persist regarding specific requirements. This article delves into the clinical evaluation routes outlined by the MDR, focusing on scenarios where limited clinical evidence suffices for...
When does software qualify as a medical device?
12 März 2024
Valentin Chapuis
1650
With fast-developing technologies, software products have become essential to the healthcare industry. While the technical development of innovative software may be relatively quick, gaining market access for a software product within the scope of medical device regulations is no walk in the park....
Summary of Safety and Clinical Performance: Plain language and health literacy principles
23 Februar 2024
Ronja Weber
1404
Creation of the Summary of Safety and Clinical Performance (SSCP) is a new requirement under the Medical Device Regulation 2017/745 (MDR) for implantable and class III devices. It is a publicly available and objective summary of the clinical evaluation, tailored to address the intended users and...
The importance of clinical evaluation planning
22 Januar 2024
Kathrin Abegg & Ronja Weber
1632
With the introduction of the Medical Device Regulation 2017/745 (MDR), the regulatory requirements for the clinical documentation of medical devices have become more challenging. Uncertainties persist about how to precisely follow the newly introduced rules, worsened by variations in how different...