ISO 13485:2016 Implementation Cost
We kindly request that you select your preferred industry from the options provided below. Please note that the fees presented are intended as a general guide only. Following receipt of your proposal request, we will provide you with a comprehensive and detailed price offer.
| ACTIVITY | OFFSITE | ONSITE |
| Drafting of Quality Manual, Mandatory Procedures, and Critical Templates in 15 to 20 working days in line with your business and process. | $ 2000 | NA |
| Guidance on standard requirements, developing the organization chart and identifying the process owners followed by process owner interaction. | $ 3000 | $7000 |
| Document Review, answering to process owner question, Internal audit training, conduct Internal Audit, Support during Stage I and Stage II Certification Body Audit | $ 3000 | $ 7000 |
| TOTAL | $ 8000 | $ 16000 |
| Payment Terms | 40:30:20:10 | 40:30:20:10 |
⇒ 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 possible.
| ACTIVITY | OFFSITE | ONSITE |
| Drafting of Quality Manual, Mandatory Procedures and Critical Templates in 15 to 20 working days in line with your business and process. | $ 3000 | NA |
| Guidance on standard requirements, developing the organization chart and identifying the process owners followed by process owner interaction | $ 3000 | $ 9000 |
| Document Review, answering to process owner question, Internal audit training, conduct Internal Audit, Support during Stage I and Stage II Certification Body Audit | $ 3000 | $ 9000 |
| TOTAL | $ 9000 | $ 21000 |
| Payment Terms | 40:30:20:10 | 40:30:20:10 |
⇒ 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 possible.
| ACTIVITY | OFFSITE | ONSITE |
| Drafting of Quality Manual, Mandatory Procedures and Critical Templates in 15 to 20 working days in line with your business and process. | $ 3000 | NA |
| Guidance on standard requirements, developing the organization chart and identifying the process owners followed by process owner interaction | $ 3000 | $ 9000 |
| Document Review, answering to process owner question, Internal audit training, conduct Internal Audit, Support during Stage I and Stage II Certification Body Audit | $ 3000 | $ 9000 |
| TOTAL | $ 9000 | $ 21000 |
| Payment Terms | 40:30:20:10 | 40:30:20:10 |
⇒ 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 possible.
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 | ONSITE |
| Drafting of Quality Manual, Mandatory Procedures and Critical Templates in 15 to 20 working days in line with your business and process. | $ 3000 | NA |
| Guidance on standard requirements, developing the organization chart and identifying the process owners followed by process owner interaction | $ 3000 | $ 9000 |
| Document Review, answering to process owner question, Internal audit training, conduct Internal Audit, Support during Stage I and Stage II Certification Body Audit | $ 3000 | $ 9000 |
| TOTAL | $ 9000 | $ 21000 |
| Payment Terms | 40:30:20:10 | 40:30:20:10 |
⇒ 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 possible.
| ACTIVITY | OFFSITE | ONSITE |
| Drafting of Quality Manual, Mandatory Procedures and Critical Templates in 15 to 20 working days in line with your business and process. | $ 3000 | NA |
| Guidance on standard requirements, developing the organization chart and identifying the process owners followed by process owner interaction | $ 4000 | $ 11000 |
| Document Review, answering to process owner question, Internal audit training, conduct Internal Audit, Support during Stage I and Stage II Certification Body Audit | $ 4000 | $ 11000 |
| TOTAL | $ 11000 | $ 25000 |
| Payment Terms | 40:30:20:10 | 40:30:20:10 |
⇒ 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 possible.
ISO 13485 Certification Cost
Certification Bodies offer ISO 13485 certifications. In every nation, there are numerous certification bodies in operation. Based on the customer demand, budget, lead time, and Implementation level, customers have to choose certification bodies.
Two different kinds of certification bodies exist. One is accredited, while the other is not. The certificates issued by non-accredited are of lower value than those granted by accredited bodies, which are more reputable and reliable.
| Certification Body Process | Non-Accredited | Accredited |
| Application Scrutiny and Issue of Proposal with details of Stage I and Stage 2 audit man-days | – | – |
| Stage I Document Review Audit | $ 500 | $ 1000 |
| Stage II Certification Audit | $ 1000 | $ 3000 |
| Issue of Certificate | $ 500 | $ 1000 |
| TOTAL | $ 2000 | $ 5000 |
⊗ The costs outlined above were calculated for small businesses with less than 10 employees. An additional fee of $500 will be applied for every additional 10 employees.
⊗ The number of audit man-days required will be determined based on several factors, including the number of employees, the size of the facility, the number of departments involved, and the range of products manufactured.
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