Skip to main content

ISO MDQMS 13485:2016 [Medical Device Quality Management System]

 


                  ISO MDQMS 13485:2016 [Medical Device Quality Management System]

ISO 13485 is an internationally published standard that outlines quality management system criteria for producers of medical devices and equipment. The primary goal of this standard is to promote standardised quality management system standards for regulatory responsibilities in the medical device sector.

ISO 13485 is a great system standard for medical device companies. It is by far the most common method of satisfying the Quality Management System (QMS). Medical equipment requirements in Europe, Canada, and Australia also serve as the foundation for QMS compliance in countries such as Japan, Korea, and Brazil.

What are the benefits of having an ISO 13485 accreditation for your company?

If you manufacture or sell a Class II or higher risk categorization equipment outside of the United Arab Emirates, you must most likely be ISO 13485 certified. ISO certification may also broaden your market access and boost your company's profitability. Here are some of the benefits of ISO 13485:

  • It is the true standard for international medical apparatus QMS compliance, and it is required for access to many key markets worldwide.
  • ISO 13485 certification necessitates time and work to obtain, but it gives you with more credibility with potential clients.
  • An attractive QMS system promotes productivity, product quality, and customer service in your company.

What is the structure of ISO 13485?

ISO 13485 is based on the criteria of ISO 9001 and has the same clause structure. The ISO 13485 standard, Medical devices - quality management systems – regulatory requirements, serves as the foundation for regulatory compliance in both domestic and most export markets. Certification displays your dedication to addressing the needs of your customers.

ISO 13485 applies to all makers and suppliers of medical devices, components, contract services, and medical device distributors. To lawfully manufacture and sell medical devices in a number of areas, ISO 13485 certification is insufficient on its own. The necessary local regulatory certification is also required.

  • Approach to risk management in product development and product realisation
  • Process verification
  • Observance of legal and regulatory obligations
  • Product tracing and recall systems that work
  • Implementation of a quality management system that has been enhanced in numerous ways.



For More Details - CONTACT:

Ms,Divyasree - HSE Advisor | Aim Vision Safety Training & Consulting 
t: 044 42140492
m: +91 9445508458
e: Admin@aimvisionsafety.co.in
#286, First Floor, GST Road, Chrompet, Chennai - 600 044 (above vodafone showroom)


www.aimvisionsafety.co.in
www.isoauditorcourse.in





Labels:

Comments

Post a Comment

Popular posts from this blog

Fire and Safety Training in Dubai - Online Training in Aim Vision Safety Training & Consulting

Fire and Safety Training in Dubai - Online Training in Aim Vision Safety Training & Consulting Introduction The primary focus should always be safety in the hectic environment of today. Being ready for emergencies is essential, whether they occur at home, at work, or in public areas. When it comes to fire safety, this is especially accurate. Fires can start at any time, imperil lives while also causing considerable property damage. To safeguard your possessions, your loved ones, and yourself, it is imperative that you engage in fire and safety training. The Importance of Fire and Safety Training People who receive fire and safety training are better equipped with the information and abilities needed to effectively avoid, respond to, and manage incidents involving fire. It gives them the assurance and skills to deal with fire situations, reducing the dangers and potential damages linked to such occurrences. You may improve both your personal and the safety of people around you by i...
Post a Comment
Read more

IOSH MS Training Centre Chennai

IOSH MS Training Centre Chennai In the modern industrial landscape, ensuring  workplace safety is more critical than ever. Companies across various sectors are prioritizing the health and safety of their employees, recognizing the immense value it brings in terms of compliance, productivity, and employee well-being. Among the myriad of certifications that contribute to workplace safety , the  IOSH Managing Safely (IOSH MS) stands out for its comprehensive approach and global recognition. For professionals in Chennai,  Aim Vision Safety Training & Consulting is the premier destination for obtaining this prestigious certification. Why Choose IOSH Managing Safely Certification? The  IOSH Managing Safely course is a well-structured program designed for managers and supervisors. It aims to impart essential knowledge and skills for managing  health and safety within their teams. The key  benefits of the IOSH MS course include: Understanding Safety Resp...
Post a Comment
Read more

Best Institute for Medic First Aid Course in Chennai

Best Institute for Medic First Aid Course in Chennai When it comes to  first aid training , having the right skills can mean the difference between life and death in emergency situations. Therefore, choosing a  top-quality institute for your Medic First Aid course is essential.  Aim Vision Safety Training & Consulting in Chennai stands out as a leading provider of comprehensive  first aid training . This blog will discuss why Aim Vision Safety Training & Consulting is the best choice for your first aid training needs, detailing its offerings, advantages, and enrollment process. Why First Aid Training is Crucial First aid training equips individuals with the knowledge and skills to handle medical emergencies effectively. Whether you're a healthcare professional, a corporate employee, or simply a concerned citizen, first aid skills are invaluable. They enable you to provide immediate care in emergencies, reduce the severity of injuries, and potentially save...
Post a Comment
Read more