Operon Strategist
Operon Strategist
Pimpri Colony, Pimpri Chinchwad, Maharashtra
GST No. 27AFMPC2555H1ZH
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Primary Packaging QMS Services

We are Offering Primary Packaging QMS Services to our Client.

ISO 13485 Certification Service

ISO 13485 Certification Service
  • ISO 13485 Certification Service
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Service Details:

Type of CertificationNew Certification
Type of Industry Chemical
Type of Service Provider Consulting Firm
Preferred LocationIndia

ISO 13485 Certification Services offered is handled by experienced professionals from the industry who have with them rich process knowledge as well as experience to support clients in gaining coveted ISO certification. Here, we have experience of serving customers ranging from small establishments to large organizations for whom we support setting up of ISO certification based business standards.

 

Some of the features include:

  • Allows client company benefits of improved financial performance as well as increased productivity
  • Supporting enhancing the efficiency and competitive edge
  • Supporting setting up and maintenance of systems that enable company to run efficiently and economically
  • Helping business maximize efficiency
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ISO 15378 Certification Service

ISO 15378 Certification Service
  • ISO 15378 Certification Service
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Service Details:

Document verification ModeOnline
Type of CertificationNew Certification
Type of IndustryChemical
Type of Service ProviderConsulting Firm

ISO 15378 Certification Service offered is handled by experienced professionals from the industry who have with them rich process knowledge as well as experience to support clients in gaining coveted ISO certification. Here, we have experience of serving customers ranging from small establishments to large organizations for whom we support setting up of ISO certification based business standards.

 

Some of the features include:

  • Allows client company benefits of improved financial performance as well as increased productivity
  • Supporting enhancing the efficiency and competitive edge
  • Supporting setting up and maintenance of systems that enable company to run efficiently and economically
  • Helping business maximize efficiency
Request
Callback
Yes! I am Interested

ISO 13485 2003 Certification Services

ISO 13485 2003 Certification Services
  • ISO 13485 2003 Certification Services
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Service Details:

Target LocationPan India
Document verification ModeOnline
Type of CertificationNew Certification
Certifications ProvidedISO 13485

ISO 13485 2003 Certification Services 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:

  • 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
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Reach Us
Anil Chaudhari (Proprietor)
Operon Strategist
MSR Capital, Office No. 10, 3rd Floor, Old Mumbai Pune Highway, Morwadi, Pimpri Colony
Pimpri Chinchwad - 411018, Maharashtra, India


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