Got some time to expand a bit about why I think achieving ISO 13485 2016 Quality Certification is a very important milestone for the company.
The ISO 13485 Certification is a proof of quality management system compliance to the standard for organizations involved in Medical Device Industry.Organizations involved in one or several stages of a medical device lifecycle or a supplier are also applicable to ISO 13485 2016.The lifecycle literally includes design and development, production and installation and so on while supplier literally means raw materials,components,sub-assemblies and so on.
In today’s announcement,we are told Sensera makes products for medical customers as well as integrated sensors into sub-assemblies.Inclusive of the role in R&D stage Sensera takes,conforming to ISO 13485 is the best approach that the company prepares global market expansion.ISO 13485 Certification should provide potential and existing customers confidence to conform with the quality standards.
Compliance with ISO 13485 is often seen as the first step in complying with Europe regulations.Plus ISO 13485 is the foundation of the auditing criteria in Medical Device Single Audit Program for five markets(Australia Brazil,Canada,Japan and USA).This Certification easily opens a few folds of market penetration for our company.
Now with this certification I am looking forward with more global business.
SE1 Price at posting:
13.5¢ Sentiment: Buy Disclosure: Held
