Quality Management System Regulation
With the FDA’s new Quality Management System Regulation (QMSR) deadline approaching on February 2, 2026, companies in the medical device industry must prepare to transition from the current Quality System Regulation (QSR) to the QMSR, which harmonizes more closely with ISO 13485. Given the complexities of this new framework, consulting with QMSR experts is critical for ensuring a smooth transition. These consultants bring specialized knowledge of both FDA regulations and international quality standards, helping companies adapt their processes, implement compliant quality management systems, and avoid costly non-conformances or delays in product approvals. Early consultation can provide strategic guidance, streamline internal adjustments, and safeguard the company’s regulatory standing as the deadline approaches
Quality Management System Regulation Implementation Fee
|
# |
ACTIVITY |
OFFSITE ($) |
HYBRID ($) |
|
1 |
Drafting of Quality Manual, Mandatory Procedures, and Essential Forms/Templates (15 to 20 Business Days) |
2000 |
-Do- |
|
2 |
Implementation Planning + Assistance in Developing the Organizational Chart, Reviewing/Defining Responsibilities and Authorities + Explanation and Guidance for Respective Process Owners |
4000 |
8000 |
|
3 |
Procedure and Record Review + Addressing Process Owner Questions + Internal Audit Training + Conducting Internal Audit |
4000 |
8000 |
|
TOTAL |
10000 |
18000 |
|
|
4 |
(Optional) Integration of ISO 13485 with QMSR |
3000 |
-Do- |
|
TOTAL |
13000 |
21000 |
|
|
5 |
(Optional) ISO 13485 Onsite /Offsite support during Certification Body audit |
2000 |
6000 |
|
TOTAL |
15000 |
27000 |
|
|
# |
ACTIVITY |
OFFSITE ($) |
HYBRID ($) |
|
1 |
Drafting of Quality Manual, Mandatory Procedures, and Essential Forms/Templates (15 to 20 Business Days) |
2500 |
-Do- |
|
2 |
Implementation Planning + Assistance in Developing the Organizational Chart, Reviewing/Defining Responsibilities and Authorities + Explanation and Guidance for Respective Process Owners |
4500 |
8500 |
|
3 |
Procedure and Record Review + Addressing Process Owner Questions + Internal Audit Training + Conducting Internal Audit |
4500 |
8500 |
|
TOTAL |
11500 |
19500 |
|
|
4 |
(Optional) Integration of ISO 13485 with QMSR |
3000 |
-Do- |
|
TOTAL |
14500 |
22500 |
|
|
5 |
(Optional) ISO 13485 Onsite /Offsite support during Certification Body audit |
2000 |
6000 |
|
TOTAL |
17500 |
28500 |
|
|
# |
ACTIVITY |
OFFSITE ($) |
HYBRID ($) |
|
1 |
Drafting of Quality Manual, Mandatory Procedures, and Essential Forms/Templates (15 to 20 Business Days) |
2000 |
-Do- |
|
2 |
Implementation Planning + Assistance in Developing the Organizational Chart, Reviewing/Defining Responsibilities and Authorities + Explanation and Guidance for Respective Process Owners |
4000 |
8000 |
|
3 |
Procedure and Record Review + Addressing Process Owner Questions + Internal Audit Training + Conducting Internal Audit |
4000 |
8000 |
|
TOTAL |
10000 |
18000 |
|
|
4 |
(Optional) Integration of ISO 13485 with QMSR |
3000 |
-Do- |
|
TOTAL |
13000 |
21000 |
|
|
5 |
(Optional) ISO 13485 Onsite /Offsite support during Certification Body audit |
2000 |
6000 |
|
TOTAL |
15000 |
27000 |
|
IEC 62304 IMPLEMENTATION SERVICE FEE (Applicable only for software developers)
| ACTIVITY | OFFSITE | ONSITE |
| Understanding software classification and drafting of applicable mandatory procedures in 15 to 20 working days | $ 3000 | NA |
| Guidance on standard requirements, and explaining /educating the process owners | $ 3000 | $ 9000 |
| Review of internal documentation, Review of records and reports along with guidance and answering to queries raised by process owners. | $ 3000 | NA |
| TOTAL | $ 10500 | $ 19500 |
| Payment Terms | 40:30:20:10 | 40:30:20:10 |
Note 01: Price quoted above is for Class A software. 20% extra added for Class B and 30% extra for Class C
Note 02: The above prices might differ depending on number of departments and employee strength.
Note 03: Expected timeline is 90-120 days with full cooperation of client team process owners
|
# |
ACTIVITY |
OFFSITE ($) |
HYBRID ($) |
|
1 |
Drafting of Quality Manual, Mandatory Procedures, and Essential Forms/Templates (15 to 20 Business Days) |
2500 |
-Do- |
|
2 |
Implementation Planning + Assistance in Developing the Organizational Chart, Reviewing/Defining Responsibilities and Authorities + Explanation and Guidance for Respective Process Owners |
4500 |
8500 |
|
3 |
Procedure and Record Review + Addressing Process Owner Questions + Internal Audit Training + Conducting Internal Audit |
4500 |
8500 |
|
TOTAL |
11500 |
19500 |
|
|
4 |
(Optional) Integration of ISO 13485 with QMSR |
3000 |
-Do- |
|
TOTAL |
14500 |
22500 |
|
|
5 |
(Optional) ISO 13485 Onsite /Offsite support during Certification Body audit |
2000 |
6000 |
|
TOTAL |
17500 |
28500 |
|
|
# |
ACTIVITY |
OFFSITE ($) |
HYBRID ($) |
|
1 |
Drafting of Quality Manual, Mandatory Procedures, and Essential Forms/Templates (15 to 20 Business Days) |
3000 |
-Do- |
|
2 |
Implementation Planning + Assistance in Developing the Organizational Chart, Reviewing/Defining Responsibilities and Authorities + Explanation and Guidance for Respective Process Owners |
5000 |
9000 |
|
3 |
Procedure and Record Review + Addressing Process Owner Questions + Internal Audit Training + Conducting Internal Audit |
5000 |
9000 |
|
TOTAL |
13000 |
21000 |
|
|
4 |
(Optional) Integration of ISO 13485 with QMSR |
3000 |
-Do- |
|
TOTAL |
16000 |
24000 |
|
|
5 |
(Optional) ISO 13485 Onsite /Offsite support during Certification Body audit |
2000 |
6000 |
|
TOTAL |
18000 |
30000 |
|
Additional Information →
- The number of onsite man-days will be explicitly specified in the official offer/proposal.
- Please note that the prices indicated above are subject to change based on the number of departments involved and the size of the client’s workforce.
- The anticipated timeline for the project is 90-120 days, provided that we receive full cooperation from the client’s team and process owners.
- The document drafting service we provide online only. No physical visit is possible.
- Payment Terms: 40% in advance, 10% upon handover of all draft documents, 20% after process owner interaction, 20% before the internal audit, and 10% upon satisfactory project handover.