TRAINING
All training opportunities
MDR Suite
The European Medical Device Regulation (EU-MDR 2017/745), officially published on May 5, 2017, and enforced on May 25, 2017, mandates stringent requirements for medical device manufacturers and Notified Bodies involved in the approval process. With the transition deadline extended to May 26, 2021, all manufacturers of Class I to III medical devices must swiftly adapt to the new regulatory landscape. The EU-MDR introduces significant changes, including reclassifications, new conformity assessment routes, and heightened safety and compliance standards, affecting all classes of medical products.
Qserve offers comprehensive training covering every aspect of MDR implementation, equipping you with the necessary skills and knowledge for a smooth transition.
Our EU MDR Training options:
-
EU Medical Device Regulations - The framework
- Is your product a medical device?
- Obligations of a Manufacturer and economic operators
- Person Responsible for Regulatory Compliance
- UDI
- EUDAMED
- The CE certification process
- Select a Suitable Notified Body
- What is the classification of your device?
- Determine the regulatory pathway
- Clinical Evaluation - Safety, Performance and Clinical Benefit
- Clinical Investigation
- PMS system
- Vigilance
- Governance Data protection
- Transitional provisions
- GSPR
- Set up the Technical Documentation
- QMS - Beyond the obvious
- Custom made devices
- PMCF
- Products without an intended medical purpose
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IVDR Suite
The In Vitro Diagnostic (IVD) industry is dedicated to designing products that deliver precise and dependable diagnoses for healthcare professionals and consumers. Strict regulations prioritize quality and safety during product development and market introduction.
Qserve's IVDR training is particularly interesting for professionals seeking to market their IVD in Europe. Our training covers all aspects of the IVDR, equipping you to navigate the transition from the IVD Directive (IVDD). Topics include classification, conformity assessment, CE marking, and labeling. We offer both online and classroom training options tailored to support IVD professionals.
Our complete IVDR Training courses or individual options:
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Clinical Suite (EU)
The MDR mandates robust clinical data to demonstrate the safety and efficacy of medical devices, essential for achieving CE marking. Moreover, ongoing clinical data collection post-market is essential to uphold patient safety standards.
Navigating through the regulations, guidance documents, and standards demands precise interpretation tailored to diverse device categories. Qserve presents a comprehensive virtual training program, designed to address manufacturers' clinical challenges. Delve into the latest requirements and guidance, ensuring a collection of important evidence for your medical device.
From clinical evaluation processes to investigations and post-market follow-ups, our sessions equip your team with the necessary expertise. Prepare your subject matter experts to implement these insights effectively within their specific areas of expertise through our specialized training sessions.
Our Clinical Training Options:
- ISO 14155 Good Clinical Practice (GCP)
- ISO 14155 GCP for investigators
- Good Clinical Practice refresher training
- Clinical evaluation
- PMCF
- PMCF Surveys
- Design of Clinical Studies
- Monitoring
- Literature searches for Medical Devices
- Literature searches for IVD
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US Regulations
Securing Food and Drug Administration (FDA) 510(k) clearance is essential for marketing medical device products in the United States. Therefore, medical device companies must carefully navigate the regulatory landscape to determine the optimal path for bringing their products to market. Understanding the requirements and timeline for completing the 510(k) process is crucial for successful submission and market entry.
Our US Regulations training options:
- 21 CFR 820 QSR
- FDA 21 CFR Part 11
- FDA Clinical Trial approaches
- FDA Approvals
- FDA Q-Submission
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China Regulations
Since the overhaul of the Chinese Medical Device Regulation in 2014, the regulatory landscape has undergone numerous updates, encompassing rules, technical guidance, and standards. To sell medical devices and in vitro diagnostics in the Chinese market, manufacturers must secure device registration with the National Medical Products Administration (NMPA).
A governmental reorganization has seen the integration of the former regulatory body, CFDA (China Food & Drug Administration), into the new CNDA (China National Drug Administration), signaling potential changes to the existing regulatory framework. The emergence of requirements such as clinical evidence, China Agents, and overseas inspections presents both opportunities and challenges for foreign medical device manufacturers.
Our China regulations training options:
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QMS & Auditing
In the medical device industry, having a quality management system is not only mandatory for manufacturers but also expected for other economic operators. However, setting up and maintaining such a system can give significant challenges, particularly for businesses lacking expertise in this domain. Our training program guides you through every phase of the process, helping you build, implement, and sustain a compliant and efficient quality management system.
To ensure compliance of your quality management system before audits from our regulatory authorities or inspection bodies take place, your company must be well-prepared.
Our QMS and Auditing Training options:
- QMS/ ISO13485
- Internal Auditing
- Lead Auditor
- MDSAP
- MDR internal auditing
- Effective Supplier Control and Audits
- Audit behavior (dos and don'ts)
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Other Medical Device Training
Ensuring consistent learning standards throughout your organization can be a challenging endeavor. It's crucial to guarantee that all personnel, both local and global, receive uniform and top-tier training. In addition to our MDR and IVDR Clinical Quality and Auditing training courses, we provide a range of in-depth courses covering specific topics to meet your organization's diverse needs.
Our Other training options:
- Basics of global regulatory approval for medical devices
- Market Access Beyond the EU and US Market
- Introduction to Risk Management ISO 14971
- Advanced Risk Management ISO 14971
- Medical Device Software (incl. AI,SaMD, cybersecurity) IEC 62304, IEC/TR 80002, IEC 80001-1
- Introduction Biological Safety Evaluation ISO 10993
- Biological Safety of Medical Devices ISO 10993
- Good documentation practices
- Introduction to hazardous substances, e.g. RoHS, REACH
- Basic Safety & Essential Performance, IEC 60601
- Usability IEC 62366-1
- Biological Safety Evaluation
- Combination products
- Devices with animal tissue derivative, ISO 22442
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