Training Courses

Simplimedica’s goal is to educate the Medical Device Industry on regulations in a world of complexity and technological advancement in healthcare, where the regulations are a continuous moving target.

Welcome to the Simplimedica training hub!

Whether you are developing a new medical device or looking to enhance your knowledge here, you’ll find a wide range of resources designed to help you develop your skills, enhance your knowledge, and succeed in your journey.

Whether you’re a beginner or looking to refine your expertise, our training materials are tailored to meet your needs. Explore our courses, and gain the tools and confidence you need to excel. Let’s get started!

Medical Device Training Courses

ONLINE - CUSTOMISED - IN PERSON

ISO 13485 – EU MDR – EU IVDR – CLINICAL EVALUATION – PROCESS VALIDATION – DIGITAL HEALTH – RISK MANAGMENT

Clinical Evaluation & Investigation Training Course

During this course we will explore the requirements for Clinical Evaluation which looks at three possible types of data.

Introduction to Design Control and Risk Management Training Course

During this course we will explore the requirements for Clinical Evaluation which looks at three possible

Introduction to Regulations for Med-Tech Start Up Companies Training Course

The Medical Device is growing at an alarming rate, much of this will be in the sectors of nanotechnology, AI, ML and Medical Device Software,

Introduction to Software as a Medical Device EN62304 Training Course

During this course we will explore the requirements for Clinical Evaluation which looks at three possible types of data.

Introduction to the EU IVDR Training Course

During this course we will explore the requirements for Clinical Evaluation which looks at three possible types of data.

Introduction to the EU MDR Training Course

During this course we will explore the requirements for Clinical Evaluation which looks at three possible types of data.

Medical Device Auditing – Internal, External, Supplier Training Course

In this course, you will learn how to Internal Audit, and what to expect from external audits such as notified bodies for CE marking, and ISO 13485 audits.

Process Equipment Validation (including software) Training Course

In this course, you will learn what to do for equipment, process, and software validation whether your equipment is basic or advanced, manual or automated.

Quality Management for Medical Devices: ISO 13485 Training Course

In this course, you will learn the essential need for a QMS as a solid foundation to your Medical Device company.
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