Role of ISO 13485 Consultants

The major role of consultants explained below. Customers have the option of choosing any of the option along based on your requirement, but normally we advice our clients to utilize our services completely
I.  Define Scope and Process Mapping
II.  Review of adherences towards regulatory compliances
III.  Training
Our Onsite consultancy starts with awareness training to all followed by training to MR and assistant MR. Internal auditor training will be provided before first Internal Audit.
Clients have the choice of utilizing our service for training along.
Please refer the fee structure
IV.  Implementation
V.  Internal Audit
We schedule our internal audit program to reach almost all activities as part of our ISO 13485/CFR 820 consultancy which in turn helps organization to face Notified Body /US FDA audit with much courage
Clients have the choice of utilizing our service for Technical consultancy, Training, Internal audit and Gap analysis.
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Advantages by appointing us

• Qualified and experienced consultants
• ISO 13485 Certified Lead Auditors
• Largest customer base
• Largest reference standard and document collection
• Offsite (online) consultancy with very normal fee
• Payments based on deliverables.
• Good reputation with all Certifying bodies.

Refer more in FAQ Section