ISO 13485 Certification Cost
ISO 13485 certification cost depends on various factors such as (a) Number and Type of Medical Device manufactured (b) Shop Floor Area etc. Below is a comprehensive estimate for the regulatory compliance of the medical device quality management system (MDQMS). We kindly request that you select your preferred industry from the options provided below.
Please note that the ISO 13485 certification cost presented are intended as a general guide only. Following receipt of your proposal request, we will provide you with a comprehensive and detailed offer covering cost too.
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[A] ISO 13485 Implementation / Consultation Cost
| ACTIVITY | OFFSITE | ONSITE |
| Drafting of Quality Manual, Mandatory Procedures, and important forms/templates
(15 to 20 working days) |
$ 2000 | NA |
| Implementation Planning + Guidance in framing organization chart, responsibilities and authorities of each individual in the Org Chart + clause-wise standard explanation to respective process owners (Timeline 2-4 months) | $ 3000 | $7000 |
| Procedure and record review + answering process owner questions + internal audit training + conduct Internal Audit + Support during Stage I and Stage II CB Audit as per request. | $ 3000 | $ 7000 |
| TOTAL | $ 8000 | $ 16000 |
| Payment Terms | 40:30:20:10 | 40:30:20:10 |
| ACTIVITY | OFFSITE | ONSITE |
| Drafting of Quality Manual, Mandatory Procedures, and important forms/templates
(15 to 20 working days) |
$ 3000 | NA |
| Implementation Planning + Guidance in framing organization chart and responsibilities, authorities of each individual in the Org Chart + clause-wise standard explanation to respective process owners (Timeline 2-4 months) | $ 3000 | $ 9000 |
| Procedure and record review + answering process owner questions + internal audit training + conduct Internal Audit + Support during Stage I and Stage II CB Audit as per request | $ 3000 | $ 9000 |
| TOTAL | $ 9000 | $ 21000 |
| Payment Terms | 40:30:20:10 | 40:30:20:10 |
| ACTIVITY | OFFSITE | ONSITE |
| Drafting of Quality Manual, Mandatory Procedures, and important forms/templates
(15 to 20 working days) |
$ 3000 | NA |
| Implementation Planning + Guidance in framing organization chart, responsibilities and authorities of each individual in the Org Chart + clause-wise standard explanation to respective process owners (Timeline 2-4 months) | $ 3000 | $ 9000 |
| Procedure and record review + answering process owner questions + internal audit training + conduct Internal Audit + Support during Stage I and Stage II Certification Body Audit as per request. | $ 3000 | $ 9000 |
| TOTAL | $ 9000 | $ 21000 |
| Payment Terms | 40:30:20:10 | 40:30:20:10 |
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 important forms/templates
(15 to 20 working days) |
$ 3000 | NA |
| Implementation Planning + Guidance in framing organization chart and responsibilities and authorities of each individual in the Org Chart + clause-wise standard explanation to respective process owners (Timeline 2-4 months) | $ 3000 | $ 9000 |
| Procedure and record review + answering process owner questions + internal audit training + conduct Internal Audit + Support during Stage I and Stage II Certification Body Audit as per request. | $ 3000 | $ 9000 |
| TOTAL | $ 9000 | $ 21000 |
| Payment Terms | 40:30:20:10 | 40:30:20:10 |
| ACTIVITY | OFFSITE | ONSITE |
| Drafting of Quality Manual, Mandatory Procedures, and important forms/templates
(15 to 20 working days) |
$ 3000 | NA |
| Implementation Planning + Guidance in framing organization chart and responsibilities and authorities of each individual in the Org Chart + clause-wise standard explanation to respective process owners (Timeline 2-4 months) | $ 4000 | $ 11000 |
| Procedure and record review + answering process owner questions + internal audit training + conduct Internal Audit + Support during Stage I and Stage II Certification Body Audit as per request. | $ 4000 | $ 11000 |
| TOTAL | $ 11000 | $ 25000 |
| Payment Terms | 40:30:20:10 | 40:30:20:10 |
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.
[B] ISO 13485 Auditing Cost
In every nation, there are numerous bodies in operation. Based on the customer demand, budget, lead time, and Implementation level, customers have to choose CB bodies.
Two different kinds of CB exist. One is accredited, while the other is not. The Certificate 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 ISO 13485 Certification cost 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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