16
Dec

ISO 13485 for medical devices manufacturers

According to information from the forthcoming MeDe Innovation Annual Conference to be held in January 2016, the global market for medical technologies will exceed $500bn per year by 2018.

The increasing needs of an ageing population together with improving healthcare in developing markets is driving this growth.

Understandably, the medical device manufacturing sector is highly regulated and products have to comply with international product certifications, including CE marking.

Benefits of ISO 13485 certification
To do business in global markets, certain quality and regulatory standards need to be met. The ISO 13485 standard is recognised by international regulators and achieving certification can speed up the time taken to get a product to market.

Certification to ISO 13485 establishes a quality management system that will demonstrate your products have been designed and manufactured to a consistent quality and standard. This will ease the process of meeting regulatory requirements in global markets.

An effective quality management system can often be regarded as a first step to achieving product certification, saving you time and money.

Other benefits include:

  • Helps manufacturers develop products that are safe and fit for purpose
  • Reduces product failure rates
  • Eases access to overseas markets
  • Improves product performance and reliability
  • Increases tendering opportunities
  • Maintains regulatory compliance


To find out how you can benefit from ISO 13485 certification, call us or complete the enquiry form on the home page.