From CE Marking to post-market obligations, regulatory knowledge plays a critical role in maintaining compliance. Sobel prepares regulatory teams through structured European regulatory affairs training, designed to build practical understanding, strengthen internal capabilities, and enable confident decision-making.
Sobel delivers European regulatory affairs training designed to build practical understanding, regulatory confidence, and internal capability.
European regulatory affairs training helps teams interpret complex regulations and apply them correctly in practice.
Well-trained teams reduce compliance risks, avoid rework, and make better regulatory decisions.
Regulatory knowledge empowers internal teams to manage registrations, post-market activities, and interactions with Notified Bodies more effectively.
Sobel’s European regulatory affairs training programs are designed to address real-world regulatory challenges. Delivered by experienced professionals, our sessions support different levels of regulatory maturity, helping organizations build strong, autonomous teams.
Our european regulatory affairs training programs are available in different modalities, depending on your regulatory focus, device portfolio, and team responsibilities.
This training is designed for professionals who need a clear and structured introduction to the CE Marking process for medical devices in Europe. It provides an overview of the European regulatory environment and explains how medical devices move from classification to certification and post-market responsibilities.
This advanced training supports professionals who already work with CE Marking and need deeper regulatory insight. The training explores complex compliance scenarios, technical documentation expectations, conformity assessment strategies, and post-market obligations. It is especially suited for teams managing higher-risk devices or facing more demanding regulatory interactions.
Focused on the role of the Person Responsible for Regulatory Compliance, this training addresses the specific responsibilities assigned under European legislation. It helps participants understand how the PRRC role fits within the broader regulatory framework, how it interacts with quality systems and post-market activities, and how to approach regulatory responsibilities in a structured and compliant manner.
This training provides a practical understanding of risk management as applied to medical devices throughout their lifecycle. Based on ISO 14971, the course explains how risk management supports regulatory compliance, product safety, and decision-making from development to post-production.
This course offers a comprehensive overview of the European Medical Devices Regulation (MDR 2017/745). It is designed to help professionals understand the structure, intent, and practical application of the regulation, supporting consistent interpretation of requirements across regulatory, quality, and product teams.
This training focuses on the regulatory framework applicable to medical devices in the United Kingdom. It supports companies that operate or plan to operate in the UK market by clarifying the structure of UK MDR 2002 and its practical implications in a post-Brexit context.
Our medical device regulatory consulting approach bridges knowledge gaps, reduces risk, and accelerates your time-to-market.
With Sobel, you eliminate uncertainty and prevent common mistakes that compromise timelines and budgets. You can also have support on these complementary services:
Support for CEP and CER development, including strategic planning, literature reviews and more.
Expert-led training programs that strengthen risk management and compliance.
Strong regulatory knowledge is a strategic asset. Sobel’s European regulatory affairs training programs help organizations build confident teams, improve compliance practices, and navigate European and UK regulatory requirements with clarity. Connect with our team to build a practical pathway to regulatory expertise in Europe.
1. Who should attend European regulatory affairs training?
These trainings are suitable for RA/QA professionals, product managers, regulatory specialists, and leadership teams involved in regulatory decision-making, submissions, post-market activities, or compliance oversight for medical devices.
2. Is European regulatory affairs training suitable for beginners?
Yes. Some courses are designed as foundational trainings, introducing key regulatory concepts and processes. Others are more advanced and intended for professionals with prior regulatory experience. Organizations can choose one or multiple trainings based on their team’s maturity level.
3. How is European regulatory affairs training delivered?
Trainings can be delivered online or on-site, depending on the course and the company’s needs. Sessions are led by experienced professionals and focus on practical interpretation of regulatory requirements rather than theoretical content only.
4. Does European regulatory affairs training replace regulatory consultancy?
No. European regulatory affairs training does not replace consultancy services. Training focuses on building internal knowledge and capability, while consultancy addresses specific regulatory projects, submissions, or technical documentation.
5. Do participants receive a certificate after the training?
Yes. Each participant receives a certificate of completion after finishing the training program.
6. Can companies combine multiple training programs?
Yes. Organizations may rely on one or multiple European regulatory affairs training programs, depending on their regulatory scope, device portfolio, and internal training objectives.
7. How can we choose the right European regulatory affairs training for our team?
The most suitable training depends on your regulatory responsibilities, experience level, and target markets. Sobel can help you identify the training programs that best align with your organization’s needs.
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