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ISO 13485 Consultants

ISO 13485 Consultants

Medical and diagnostic device manufacturers, along with related service organizations, must appoint experienced ISO 13485 consultants to ensure compliance with MDQMS. With hands-on knowledge of different risk-class devices and state-of-the-art production facilities, our consultants provide comprehensive support to help your organization meet ISO 13485 requirements efficiently.

 

We ensure every organization has effective systems to track and monitor safety and benefit-risk information throughout the product lifecycle. Whether you are seeking ISO 13485 Implementation or certification for the first time or improving an existing QMS, our expert consulting service provides tailored solutions for seamless compliance and market approval.

Consultants play a key role in identifying and incorporating product-specific regulatory requirements, such as MDR, IVDR, or FDA 510(k), during implementation. This proactive approach streamlines future processes for CE marking or 510(k) clearance.

Efficient and Reliable ISO 13485 Consultants Responsibilities

ISO 13485 Consulting organizations play a critical role in helping medical devices, Invitro diagnostic devices and allied medical industries and service organizations to plan, implement, and maintain a compliant Quality Management System (QMS). Their key responsibilities include:

 

  • Identifying QMS standard requirements and ensuring alignment with your process and organization goals and expectations.
  • Determining applicable legal and regulatory requirements based on the product’s classification and target markets.
  • Establishing a stage-wise implementation approach to meet ISO 13485 standard requirements efficiently.
  • Identifying all legal and regulatory requirements based on the product’s classification.
  • Planning for establishing the standard requirements stage-wise.
  • Developing and defining the processes and their documentation
  • Providing training to the QMS team
  • Establishing a proactive approach to enhance QMS effectiveness and efficiency.
  • Ensuring ongoing compliance through systematic evaluations and internal audits.
  • Organizing Management Review Meetings
  • Developing a continual improvement approach for the whole QMS
  • Evaluating the effectiveness of the QMS implemented in the organization

A well-structured QMS not only ensures compliance but also strengthens product safety, process efficiency, and regulatory approval pathways such as CE Marking and FDA 510(k) clearance.

We are ISO 13485 consultants and regulatory experts for MDR, IVDR and FDA. We guide and understand the organization’s requirements in line with the product compliance team for proper implementation.

ISO 13485:2016 Quality Manual

A quality manual is considered the mother document in a QMS system designed for medical device manufacturers. If you are manufacturing medical devices for use in the EU region with CE Marking, you will need to prove compliance with EN ISO 13485:2016. ISO 13485 certification provides flexibility in how organizations choose the structure of the quality manual or how it should be circulated.

ISO 13485 CONSULTANTS

ISO 13485:2016 follows the PDCA cycle (Plan, Do, Check, and Act), which helps to adopt a drive for continuous perfection in the processes of the organization. This approach can improve any process by dividing it into smaller steps, is effective for the implementation of QMS, and helps to improve the whole product realization process. Also, it provides a range of solutions to problems and helps to select the best one for implementation. This method helps with the proper allocation of resources, avoiding waste, for the successful implementation of the solutions.

ISO 13485:2016 Mandatory Procedures

ISO 13485-implemented organizations can have many types of procedures, ISO standard operating procedures, work instructions, or standard operating procedures, work instructions, or protocols based on the processes and activities.

 

ISO 13485:2016 Throughout the standard, in multiple places, it has used words such as “shall, should, must, documented procedures,” which directly warns the organization to keep documentation in the form of procedures. These procedures are commonly called mandatory procedures.

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Essential Staes ISO 13485:2016 Implementation and Certification

ISO 13485:2016 certification, an organization must be able to provide medical devices and related services that consistently fulfil customer and regulatory criteria. This is done by demonstrating its capacity to implement a quality management system.

 

The design and development, manufacture, storage, distribution, installation, or servicing, as well as the design and development of related services like technical assistance, are all activities that these firms may be involved in at one or more phases of the life cycle.

 

  • Planning the quality system
  • Meeting regulatory requirements
  • Implementing design controls
  • Documents, records, and training
  • Management processes
  • ISO 13485 Consultants Audit
  • Third-party or CB audits

We are ISO 13485 consulting professionals and lead auditors for medical device and in-vitro diagnostic device manufacturers. We understand organizations and frame the QMS implementation, forecasting MDR, IVDR, and FDA 510(k) product certification requirements in mind

Frequently Asked Questions

Do you provide online support for ISO 13485 Implementation?

Yes, we provide online and onsite service based on customer requests.

How long to implement a strong ISO 13485 system?

With the help of process owners, the implementation and certification can be completed in 3-4 months.

Which all cities you provide onsite service?

Service is available in Boston, Bangalore, Chicago, Chennai, Cambridge, Dusseldorf, Delhi, Dallas, London, Mumbai, Newyork, Los Angeles, Minnesota, Houston, San Diego, Seattle, Nashville, and Salt Lake City