The need for some form of a Quality Management System (QMS) has been a long-term requirement for Medical Device manufacturers.    Under the old regulations a certified quality management system was not specifically required for lower risk Medical Devices but manufacturers have always been obliged to have a manufacturing control function, and related procedures and records, particularly in respect of document control, traceability, vigilance and complaint reporting, and validation necessities. Now the international standard ISO 13485 has become the gold standard for companies to work to and conformity to EN ISO 13485:2016 which has become expected and, particularly for higher class Medical Devices, to be separately certified by their Notified Body. This Quality Management System standard describes the way a company should incorporate common sense control of their design processes, manufacturing, packaging, sterilisation and finish processing, and dispatch to the end user. In addition the standard discusses the need for post market activities through to the end the end of life of a medical device – Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF), so much that it is now considered as essential. Under the new European Medical Device regulations ISO 13485 is an important adjunct to demonstrate that company has control to meet its legal route and regulatory responsibilities, and in particular the need to comply to product liability requirements. Antex Medi Solution specialise in the creation, installation and day-to-day monitoring of Medical Device Quality Management Systems for all manufacturing and related services. Antex Medi Solution is able to create paper systems or electronic systems which may be accessed from anywhere in the world.

ISO 45001: 2018 is an International Standard that specifies requirements for an occupational health and safety (OH&S) management system, with guidance for its use, to enable an organisation to proactively improve its OH&S performance in preventing injury and ill-health. Health and safety training is provided in order to make sure that the people who work for you know how to work safely without any risk. It develops a positive health and safety culture within the organisation. It also helps you to fulfil your legal duty to protect the health and safety of your employees. It is all about what they should and should not do during their workplace activities. Everyone should be up date about how to identify the hazards and control of risks. Suitable training about health and safety can reduce workplace incidents and accidents, which in return can reduce costs and promotes safer, healthier and happier workforce. ANTEX offers you health and safety training as well as development solutions for your organisation.

No matter the size of your organization, medical device training help you to navigate the complexities of required regulations and standards, and provides a high level of safety to patients and healthcare professionals. In the new challenges of meeting regulatory requirements and maintaining quality management system, we are offering you diverse medical device training portfolios consisting of specialized training classes. To help medical device manufacturers understand the additional requirements of the standard, we have developed the training according to new European rules (EU) 2017/745.

Environmental Management Training Course helps you to improve your environmental and sustainability practices according to ISO 14001. The training provides knowledge and skills to support the introduction and maintenance of the environmental management standard ISO 14001 within your organisation. It make you able to demonstrate environmental and social responsibility to your employees, also it helps your organisation to avoid prosecution, litigation and loss of reputation. You will be assessed on your ability to apply your skills and knowledge to a wide range of issues and how to deliver positive change to a real workplace.

First Aid Training allows an average person to respond against on the spot medical emergencies. The program is based upon the 2015 International Consensus on Cardiopulmonary Resuscitation (CPR).   This is a registered training course and globally recognized. This training program is designed specifically for the occupational first aid provider and fulfills industry requirements. The course is based on the current guidelines for CPR and First Aid. This course help worker to manage a medical emergency, also demonstrate the latest concepts of workplace first aid according to latest guideline.

Social accountability is an important component of an overall good governance framework. Social Accountability Training Course provides the skills necessary to design effective, context-specific initiatives at the local level according to SA 8000, BSCI and Sedex. These standards measure the performance of organizations in eight key areas: child labor forced labor health & Safety, freedom of association and collective bargaining, discrimination, disciplinary practices, working hours and remuneration.  We offer a range of SA 8000:2014/ BSCI/ SEDEX training courses designed to help you achieve one of the most widely recognised Social accountability management systems worldwide - giving employees clearly defined roles and responsibilities.