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Turn Vision into Velocity with the Innovation CRO

Traditional CROs fragment device development with costly hand-offs and learning curves. Veranex unites the essential disciplines for medical device & diagnostic development under one roof from sketch to evidence-generation to market launch.

All connected. All aligned. All accelerating your path to market—delivering breakthrough devices and diagnostics that improve patient lives sooner.

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Outcome-Driven Solutions for Medtech Challenges

Breakthrough innovation requires more than great solutions; it demands deep expertise and insight. Veranex packages outcome-driven solutions with 25+ years of specialized knowledge across major medtech categories, delivering integrated capabilities that solve your most pressing challenges faster and with greater certainty.

Purpose-built solutions. Proven results. User & Patient-centered innovation.

 

Solutions

Expertise

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Purpose-Built for Breakthroughs

Whether you're transforming patient care or disrupting entire therapeutic categories, innovation requires more than great science, it demands velocity.  Veranex was founded to bridge the gap between visionary concepts and market reality, combining proven expertise with agile execution to accelerate the innovations that matter most.  

We are the Innovation CRO.

Legacy of excellence. Proven execution. Patient impact accelerated.

 

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Medtech Training Solutions Designed by Industry-leading Consultants

Get certified and stay ahead of competitors with comprehensive training that combines practical knowledge and real-world application, allowing you to demonstrate your expertise in today's most critical industry topics.

Online and Tailored Medtech Training Courses

Our training courses offer in-depth knowledge and practical guidance in medical device and in vitro diagnostic (IVD) across regulatory affairs (including FDA, EU IVDR, EU MDR training, and others), quality assurance, clinical affairs, digital health, and biocompatibility.

Built on decades of global medtech consulting experience, our trainers are some of the industry's most respected specialists who have successfully guided hundreds of medical devices and IVDs through complex approval pathways.

Whether you're seeking individual certification through our online group sessions or looking to equip your entire team with targeted knowledge on specific topics, Veranex delivers industry-leading medtech training solutions tailored to your unique requirements.

What's New

Upcoming Certified Medtech Training: Online Group Sessions

Our training sessions cover a wide range of topics in the medtech field and take place online. See below our planned sessions and contact us if you are interested in a specific topic.

Clinical Investigation of Medical Devices ISO 14155

Clinical Investigation of Medical Devices ISO 14155

Gain essential expertise in ISO 14155:2020 standards and regulatory compliance for medical device clinical research. Swissethics-certified GCP training.

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Training: Clinical Investigation of Medical Devices ISO 14155

IVDR Impact on Clinical Trial Assay and Companion Diagnostic Development

IVDR Impact on Clinical Trial Assay and Companion Diagnostic Development

This expert-led course clarifies IVDR and CTR compliance requirements for clinical trial assays, defining clear responsibilities for sponsors and manufacturers.

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Training: IVDR Impact on Clinical Assays

Training: Person Responsible for Regulatory Compliance (PRRC)

Training: Person Responsible for Regulatory Compliance (PRRC)

This comprehensive course clarifies qualification requirements, implementation strategies, and outsourcing options while addressing QMS documentation impacts.

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Training: PRRC

Introduction to EU Regulatory Pathways for US Companies

Introduction to EU Regulatory Pathways for US Companies

Learn CE marking processes, Notified Body roles, classification rules, and QMS certification requirements through interactive sessions designed specifically for US medical device professionals.

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Training: Introduction to EU Regulatory Pathways For US Companies

Basic Biocompatibility

Basic Biocompatibility 

This foundational course covers ISO 10993 standards, risk-based approaches, and EU MDR requirements through practical exercises and case studies.

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Training: Basic Biocompatibility

Internal & Supplier Audit 

Internal & Supplier Audit 

This interactive two-day course covers audit planning, conduct, ethics, and effective use of results to maintain QMS effectiveness. 

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Training: Internal and Supplier Audit

What Participants Say
01

“The content was clearly structured and easy to follow. The exercise in the middle was useful since it showed in practice what was taught.”
02

“Very comprehensive, and all the clinical trial aspects were explained in very accurate and clear way.”
03

“This training was extremely relevant to my day-to-day work. It gave a very overview of everything regarding ISO 14155, in the perfect amount of depth.”

On-Demand Customized Medtech Training 

Veranex offers a comprehensive range of topics that support your internal teams with a deeper understanding of IVD and medical device regulatory affairs, quality assurance, and clinical development processes that drive successful product outcomes.

  • Flexible delivery: Virtual sessions or on-site at your facilities
  • Customized duration: From focused workshops to comprehensive certification programs
  • Tailored content: Designed around your team's specific needs and regulatory challenges
  • Expert instruction: Led by seasoned consultants with real-world medtech experience
Category
EU Market Access for Medical Devices
EU Market Access for Medical Devices
Get familiar with EU Regulations for Medical Devices (MDR & IVDR). Understand Quality Management System (QMS) in compliance with ISO 13485:2016.
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Regulatory Compliance for UK, Australia, Switzerland and Canada
Regulatory Compliance for UK, Australia, Switzerland and Canada
Understand the main regulatory contexts of these four major markets. Get an overview and compare the requirements to access each jurisdiction.
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Regulatory Requirements for Economic Operators
Regulatory Requirements for Economic Operators
Understand the obligations of importers, distributors and authorized representatives for medical devices and IVDs. Learn the process for handling initial selection criteria, evaluation, monitoring and re-evaluation.
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EUDAMED
EUDAMED
Learn to interpret EUDAMED’s functional specifications, data structures, business rules and data exchange requirements. Understand the impact of EUDAMED on economic operator QMS.
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Person Responsible for Regulatory Compliance (PRRC)
Person Responsible for Regulatory Compliance (PRRC)
Understand the regulatory context of PRRC roles, responsibilities, qualification requirements, EUDAMED registration, and impact on QMS processes.
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EU MDR Overview
EU MDR Overview
Understand the key requirements in the European MDR framework. Learn to analyze the regulatory requirements and their impact on your product portfolio, and ensure you are MDR compliant.
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EU IVDR Overview
EU IVDR Overview
Understand the key requirements in the European IVDR framework. Learn to analyze the regulatory requirements and their impact on your product portfolio, and ensure you are IVDR compliant.
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Introduction to Technical Documentation
Introduction to Technical Documentation
Get to know the relevant documents required for MDR/IVDR compliance and learn how to present information in a clear and comprehensive way.
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US Regulations for Medical Devices
US Regulations for Medical Devices
Understand the basis of US medical device regulations and the main regulatory pathways.
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Active Medical Devices – What Needs to be Considered?
Active Medical Devices – What Needs to be Considered?
Learn CE-Marking procedures, IEC/EN 60601 standards and relevant evaluation procedures. Understand cybersecurity requirements, data protection and software development according to IEC 62304.
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Active Implantable Medical Device
Active Implantable Medical Device
Understand the general regulatory framework of active implantable medical devices in the EU and US. Get high-level considerations related to V&V and the criticalities of managing testing at component level and at system level.
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Combination Products
Combination Products
Learn about regulatory requirements for combination products in the EU and US.
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Substance-based Products
Substance-based Products
Learn about how substance-based products are qualified and classified in the EU including additional specific regulatory requirements for such product introduced by the MDR.
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Regulatory Framework for AI/ML based Medical Devices in the US and EU
Regulatory Framework for AI/ML based Medical Devices in the US and EU
Brief overview of key standards guiding the development, verification, and validation of AI-enabled medical device software.
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UDI, Labels, IFU
UDI, Labels, IFU
Understand the requirements, impact and implementation of the UDI (Unique Device Identification) system. Learn about IFU (Instructions for Use), discover how MDR and IVDR impact your device marking, labelling and IFU.
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PMS Overview
PMS Overview
Learn to implement MDR/IVDR-compliant PMS systems, including PMS Plans, PSURs, and vigilance reporting. Understand data collection, trend analysis, and regulatory documentation to ensure continuous safety monitoring and regulatory compliance throughout the device lifecycle.
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GDPR and HIPAA
GDPR and HIPAA
Learn to navigate the requirements of the General Data Protection Regulation (EU) 2016/679 ("GDPR") and HIPAA. Understand the applicability of GDPR during Clinical Investigations and ISO 14155.
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Risk Management for Medical Devices and IVD
Risk Management for Medical Devices and IVD
Understand ISO 14971-based risk management principles, including tools and methodologies used to identify, assess, and mitigate safety risks throughout the product lifecycle.
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Cybersecurity and Data Protection for Medical Devices and In Vitro Diagnostics
Cybersecurity and Data Protection for Medical Devices and In Vitro Diagnostics
Understand key regulatory and cybersecurity requirements under MDR/IVDR, NIS-2, GDPR, and the Data Act, including risk management, data protection, IT security, and data sharing obligations.
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Verification & Validation (V&V) for Medical Devices
Verification & Validation (V&V) for Medical Devices
Understand how to implement V&V within the design and development process. Learn methods to define the V&V plan and considerations for designing test samples. Define statistically-justified sampling strategies and understand their links with risk management activities.
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EN 62304 Software Lifecycle
EN 62304 Software Lifecycle
Understand regulatory considerations on software as a medical device (SaMD). Learn the key concepts associated with IEC 62304.
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EN 60601 Electrical Requirements
EN 60601 Electrical Requirements
Understand basic electrical & mechanical safety. Understand the risk management related to IEC 60601 and learn to interpret test reports for different markets.
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EU Batteries Regulation for Medical Devices
EU Batteries Regulation for Medical Devices
Understand the EU 2023/1542 Batteries Regulation, including battery-related requirements for medical devices (e.g.: Articles 6, 7, 8...), implications, deadlines and insights.
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Usability
Usability
Understand how to integrate usability activities into the design process and engineering file. Learn the basics of usability requirements according to IEC 62366.
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ISO 13485:2016 Medical Device Quality Management Systems – Regulatory Requirements
ISO 13485:2016 Medical Device Quality Management Systems – Regulatory Requirements
Understand QMS basic principles and architecture. Dive into the details of each ISO 13485 process (management responsibility, resource management, product realization, measurement analysis and improvement).
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QMS transition to EU MDR/ IVDR
QMS transition to EU MDR/ IVDR
Understand key changes introduced by EU regulations (MDR/IVDR) and assess their impact on QMS processes. Establish and implement a transition plan.
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QMSR Implementation (USA Regulation)
QMSR Implementation (USA Regulation)
Understand the US Regulations focusing on 21 CFR Part 820, discuss key differences between EU and US regulations, and prepare for FDA inspections.
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Internal and Supplier Audit
Internal and Supplier Audit
Understand the specificities of internal and supplier audits, including how to prepare and organize them. Learn how to classify audit results and generate an audit report.
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CAPA (Corrective Action / Preventive Action)
CAPA (Corrective Action / Preventive Action)
Understand the regulatory requirements of CAPA and the creation of logical links related to CAPA within QMS. Learn different techniques for root cause identification and determination of correction, corrective/preventive actions.
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MDSAP Audit Program
MDSAP Audit Program
Understand MDSAP principles and approach. Learn the main requirements of the MDSAP audit processes, the structure and scope. Get familiar with the legal framework for medical devices in MDSAP jurisdictions.
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ISO 27001 ISMS
ISO 27001 ISMS
Learn basics of information security management system (ISMS), including an introduction to ISO 27000 family, requirements of ISO 27001, and certification options.
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Clinical Evaluation of Medical Devices under EU MDR
Clinical Evaluation of Medical Devices under EU MDR
Understand clinical evaluation under MEDDEV 2.7/1 Rev. 4 and MDR Article 61, including MDCG guidance, to ensure sufficient clinical evidence, regulatory compliance, and readiness for conformity assessment through robust planning, data appraisal, and benefit-risk evaluation.
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Performance Evaluation of IVD under EU IVDR
Performance Evaluation of IVD under EU IVDR
Learn to generate and assess scientific validity, analytical and clinical performance data under IVDR Article 56, and document performance evaluation to meet regulatory requirements, ensure sufficient clinical evidence, and achieve conformity assessment readiness.
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GCP ISO 14155:2020 for MD
GCP ISO 14155:2020 for MD
This training emphasizes Good Clinical Practice in the design, conduct, documentation, and reporting of clinical investigations involving medical devices in human subjects, ensuring ethical standards, scientific validity, and regulatory compliance throughout the clinical research process.
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GCP ISO 20916:2019 for IVD
GCP ISO 20916:2019 for IVD
This training highlights Good Study Practices in designing, conducting, documenting, and reporting clinical performance studies using human specimens to evaluate the safety and clinical performance of in vitro diagnostic medical devices for regulatory purposes.
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Biocompatibility – Introduction to ISO 10993-1
Biocompatibility – Introduction to ISO 10993-1
Understand the concept of biological evaluation, including the basics of the ISO 10993 series, the biological evaluation process within the ISO 14971 risk management framework, and the structure of the biological evaluation plan and report. Get introduced to chemical characterization and biological effects.
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Explore Our Preclinical Training Service

Looking for hands-on surgical training and regulatory protocols? Our preclinical programs deliver the same evidence-based approach that's helped validate devices now treating over 1 million patients.

Learn More About Our Preclinical Training

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IVD and Medical Device Consulting Services Supporting Your Team Achieve Results Faster

Regulatory Consulting 

 

Get our team’s support in leading your project to success with expert regulatory strategy and compliance support services.

Regulatory Consulting 

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Quality Consulting 

 

Our consultants work with you to build robust quality management systems that ensure compliance and operational excellence across your entire product lifecycle.

Quality Consulting 

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Medical Device CRO

 

Have our teams accelerate your clinical development with comprehensive CRO services, from study design to submission support.

Clinical Trial Services

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Biocompatibility & Toxicology 

 

Ensure patient safety with our comprehensive biocompatibility testing and toxicological risk assessment services.

Biocompatibility Services

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Ready to Boost Your Results with Specialized Medtech Training?

Ensure your organization stays ahead of evolving medtech subjects while building internal capabilities that drive long-term success.

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