ISO 13485 Certification Bangalore

ISO 13485




The Standard


ISO 13485:2003, Medical Devices- Quality Management System – Requirements for Regulatory Purposes


A Brief Overview


ISO 13485 standard deals with the fundamentals of quality management systems with respect to the design and manufacture of Medical Devices


ISO 13485 standard is based on ISO 9001 standard with additional requirements related to regulatory compliances for the medical devices, but it has some exclusions from the ISO 9001 standard .


The ISO 13485 standard is specific in nature and is applicable to any organization providing medical devices regardless of type, size and product.


The ISO 13485 standard focuses more on the risk management, design controls, specific requirements for inspection and traceability for implantable devices, validation processes for sterile medical devices.


The ISO 13485 standard is basically adopted from the EN standards, later released as an ISO standard in 1996. First revision in 2003 (presently in use)


Main Clause Requirements of the ISO 13485 Standard


Clause 1. Scope

Clause 2. Normative References

Clause 3. Terms and Definitions

Clause 4. Quality Management System

Clause 5. Management Responsibility

Clause 6. Resource management

Clause 7. Product / Service Realization

Clause 8. Measurement, Analysis and Improvement


Advantages of ISO 13485 Certification


ISO 13485 certified organization has a better edge over increasing the profitability of making safe and effective medical devices.

ISO 13485 certification for an organization will meet the regulatory requirements and customer expectations.

Increased efficiency and cost saving is a key factor from an ISO 13485 certified organization

An ISO 13485 certificate enhances the marketing image of the organization.

ISO 13485 certification helps in more effective risk management and quality assurance.

An unique way of having a standardization process across the world with promotion of international trade.



Why choose ORBITQMS as your ISO 13485 Partner!


We are one of the most successful ISO 13485 certification consultants in Bangalore, India. We have experience working with all the reputed certification agencies across the world. We have resources with rich technical expertise with strong ISO 13485 consulting knowledge for ISO implementation, ISO Training and ISO Audits. We follow a unique technique as ISO 13485 consultants for training, consulting and audits which are less complicated, faster, result oriented and with cost effectiveness. We provide an end to end solution to any client in offering services from gap analysis for ISO 13485 till the ISO 13485 certification is achieved. We have experience in catering ISO 13485 consulting services and ISO 13485 certification services to a wide spectrum of sectors like ISO 13485 for manufacturing sector, ISO 13485 for Software sector, ISO 13485 for Healthcare sectors, ISO 13485 for Educational sectors, ISO 13485 for service sectors etc.

ORBIT QMS is one of the biggest ISO 13485 Certificate consultants in Bangalore with a long list of prestigious clientele in all segments of the industry. We have experience in ISO 13485 implementation ranging from a small scale industry to a multinational with a different approach for each client. We believe in adding value to the client when we are offering our ISO 13485 consulting services. We have a 100% success rate in getting our clients ISO 13485 certification in Bangalore during the first audit itself.

As we are an ISO 13485 consultants in Bangalore we provide a one stop solution for your ISO 13485 Certification in Bangalore , ISO 13485 Consultants in Bangalore, ISO Documentation in Bangalore, ISO 13485 Trainings in Bangalore , ISO 13485 Internal audits in Bangalore , ISO 13485 Audits in Bangalore.

Orbit QMS offers all other international certifications & Accreditations like ISO 9001, ISO 14001, ISO 15189, ISO/TS 16949, ISO 17020, ISO 17025, OHSAS 18001, ISO 22000, ISO 27001, AS 9100, SA 8000, NABL Accreditations , NABH Accreditations, NAAC Accreditations, School Accreditations, Product Markings like CE mark, ISI mark etc.

Contact Santosh on + 91 9845154021 or mail to for ISO 13485 Consultants , ISO 13485 Certifications in Bangalore

Contact Now and Get ISO 13485:2003 Certified.


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