Quality Advisors
Quality Advisors
CBD Belapur, Navi Mumbai, Thane, Maharashtra
GST No. 27AAHPZ5528M1ZV
TrustSEAL Verified
Call 08048114660 88% Response Rate
SEND EMAIL

Iso 13485 Certification Services

Pioneers in the industry, we offer iso 13485:2016 certification from India.

ISO 13485:2016 Certification

ISO 13485:2016 Certification
  • ISO 13485:2016 Certification
Get Best Quote
Approx. Price: Rs 30,000 / PersonGet Latest Price

Service Details:

Type of IndustryFood
Certificate TypeNew Certificate,Renewal
Document Verification ModeDoor Step/ Office Step
Location PreferencesIndia,Gulf-Countries,USA
Mode of ReportSoft Copy,Hard Copy

ISO 13485:2003 is a quality system standard designed specifically for medical device companies. The ISO 13485 standard has many of the same requirements as ISO 9001. However, there are additional requirements for process control, design control, retention of records, accountability, traceability and more.

 

ISO 13485 is the most commonly chosen path for medical device companies to meet the quality system requirements in Europe, Canada, Japan, Australia and other countries. Although implementing ISO 13485 is voluntary for manufacturers selling in Europe, most companies opt to apply this standard to demonstrate compliance with the Directives. In Canada, ISO 13485:2003 is mandatory for Class II, III and IV medical device manufacturers (with additional requirements imposed under Canadian law). Compliance with Japan’s Ministerial Ordinance #169 is quite similar to ISO 13485 with additional requirements imposed under Japan law.


Advantages of ISO 13485 certification:

As we mentioned, ISO 13485 certification is not mandatory in most markets. Here is how your company can benefit from ISO 13485:2003 certification: :

  • Compliance with European standards offers straightforward access to the Japanese, Australian and New Zealand markets

  • Other countries around the world also recognize ISO 13485 as a means of meeting their quality requirements

  • ISO 13485 is a globally recognized standard and having this certification will increase the credibility of your company with potential customers.

  • Certification can lead to increased efficiency, better product quality, and improved customer service within your company

  • Demonstrate your consumers and partners a commitment to quality

 

Request
Callback
Yes! I am Interested
X

Explore More Service



Reach Us
Bhaskar Zinjurde (Director)
Quality Advisors
A-414, Shiv Chamber, Plot No. 21, Sector 11
CBD Belapur, Navi Mumbai - 400614, Thane, Maharashtra, India


Call Us


Send E-mailSend SMS