ISO 13485:2016 Implementation Cost
The type of Industry should be chosen by viewers from the options listed below. The fees are listed here as a guide only. Once we get your request for a proposal, we will send you a 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. | $ 1500 | NA |
| Guidance on standard requirements, developing the organization chart and identifying the process owners followed by process owner interaction | $ 2000 | $ 7000 |
| Document Review, answering to process owner question, Internal audit training, conduct Internal Audit, Support during Stage I and Stage II Certification Body Audit | $ 2000 | $ 7000 |
| TOTAL | $ 5500 | $ 15500 |
| Payment Terms | 40:30:20:10 | 40:30:20:10 |
Note 01: Onsite man-days will be limited and detailed in the official offer/proposal.
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. | $ 1500 | 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 | $ 7500 | $ 19500 |
| Payment Terms | 40:30:20:10 | 40:30:20:10 |
Note 01: Drafting of documents only offline.
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. | $ 1500 | 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 | $ 10500 | $ 19500 |
| Payment Terms | 40:30:20:10 | 40:30:20:10 |
Note 01: Drafting of documents only offline.
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
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. | $ 1500 | 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 | $ 7500 | $ 19500 |
| Payment Terms | 40:30:20:10 | 40:30:20:10 |
Note 01: Drafting of documents only offline.
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. | $ 2000 | 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 | $ 10000 | $ 24000 |
| Payment Terms | 40:30:20:10 | 40:30:20:10 |
Note 01: Drafting of documents only offline.
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
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 |
Note 01: The aforementioned costs were computed for small businesses with fewer than 10 employees. Additional $500 is applicable for every 10 employees.
Note 02: The audit man-days will be added based on the number of employees, area, departments, and products manufactured.
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