Training
We offer on-site customisable group training where we aim to provide specific requested elements of the subject training in a targeted, interactive and practical manner leading to a improved learning experience for all candidates.
List of services
-
Cleaning Validation
Cleaning Validation
-
Software Validation
Software Validation
-
Equipment Validation
Equipment Validation
-
Fundamentals of Calibration
Fundamentals of Calibration
-
ISO 13485:2016
ISO 13485:2016
-
Process Validation
Process Validation
-
Project Management for Medical Device Companies
Project Management for Medical Device Companies
-
Risk Management of Medical Devices
Risk Management of Medical Devices
-
ISO 9001:2015
ISO 9001:2015
-
Internal Auditing
Internal Auditing
-
Design of Experiments
Design of Experiments
-
Technical Writing
Technical Writing
-
First Steps to Medical Device manufacturing
First Steps to Medical Device manufacturing
-
Business Continuity Management
Business Continuity Management
-
FDA Audit Preparation
FDA Audit Preparation
-
Designing of QMS (Quality Management System)
Designing of QMS (Quality Management System)
-
CAPA Corrective and Preventive Action
CAPA Corrective and Preventive Action
-
Design Control for Medical Devices
Design Control for Medical Devices
-
Product Innovation
Product Innovation
-
Understanding Clinical Evaluations and Post Market Clinical Follow Up
Understanding Clinical Evaluations and Post Market Clinical Follow Up
-
Good Laboratory Practice
Good Laboratory Practice
-
ISO 17025:2017
ISO 17025:2017
-
Internal Auditing to ISO 17025:2017
Internal Auditing to ISO 17025:2017
-
Quality Risk Management and ISO 14971:2019
Quality Risk Management and ISO 14971:2019
-
Documenting ISO 9001:2015 Quality Management System
Documenting ISO 9001:2015 Quality Management System
-
Documenting ISO13485:2016 Quality Management System
Documenting ISO13485:2016 Quality Management System
-
Contamination control within the Cleanroom
Contamination control within the Cleanroom
-
Cleanroom Good Manufacturing Practice (GMP)
Cleanroom Good Manufacturing Practice (GMP)
-
ISO13485:2016 Lead Auditor
ISO13485:2016 Lead Auditor
-
ISO 13485:2016 Internal Auditor Training
ISO 13485:2016 Internal Auditor Training
-
I.S. EN 14065 : 2016 RABC (Risk Analysis Biocontamination Control)
I.S. EN 14065 : 2016 RABC (Risk Analysis Biocontamination Control)
-
Steam Sterilization Training
Steam Sterilization Training
-
Periodic Safety Update Report (PSUR) Writing
Periodic Safety Update Report (PSUR) Writing
-
EU Medical Device Regulation MDR (2017/745)
EU Medical Device Regulation MDR (2017/745)
-
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course
-
Data Integrity
Data Integrity
-
Good Distribution Practice (Storage, Transportation, Cold Chain)
Good Distribution Practice (Storage, Transportation, Cold Chain)
-
Distribution of Medical Devices, including in vitro diagnostic Medical Device
Distribution of Medical Devices, including in vitro diagnostic Medical Device
-
PRRC (Person Responsible for Regulatory Compliance)
PRRC (Person Responsible for Regulatory Compliance)
-
Change Management within QMS
Change Management within QMS
-
Leadership and Change Management
Leadership and Change Management
-
Preventative Maintenance
Preventative Maintenance
-
U.S. FDA Quality Systems Regulation (QSR) 21 CFR 820 Course
U.S. FDA Quality Systems Regulation (QSR) 21 CFR 820 Course
-
ISO 9001 Implementation Training Course
ISO 9001 Implementation Training Course
-
ISO 13485:2016 Implementation Training Course
ISO 13485:2016 Implementation Training Course
-
Construction of a Technical File in Line with MDR Training Course
Construction of a Technical File in Line with MDR Training Course
-
Root Cause Analysis for Plastics and Polymer Industries
Root Cause Analysis for Plastics and Polymer Industries
-
ISO 31000:2018 Risk Management Fundamentals Training Course
ISO 31000:2018 Risk Management Fundamentals Training Course
-
Root Cause Analysis Training for HSE and Healthcare Professionals
Root Cause Analysis Training for HSE and Healthcare Professionals
-
Understanding ISO 22301 Business Continuity Training
Understanding ISO 22301 Business Continuity Training
-
Fundamentals of Medical Device Design and Development
Fundamentals of Medical Device Design and Development
-
Medical Device Software Requirements: A Regulatory Overview
Medical Device Software Requirements: A Regulatory Overview
-
Cleanroom Contamination Control
Cleanroom Contamination Control
-
Project Management Fundamentals
Project Management Fundamentals
-
FMEA
FMEA
-
ISO 14971:2019 Application of risk management to medical devices
ISO 14971:2019 Application of risk management to medical devices
-
Complaint Management
Complaint Management
-
GAMP
GAMP
-
21 CFR Part 11- Software Validation
21 CFR Part 11- Software Validation
-
Usability Engineering - Medical Device Design
Usability Engineering - Medical Device Design
