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ISO 13485 CERTIFICATION

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 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 ISO 13485 certification cost too.

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.

Accredited & Non-accredited ISO 13485 Certification Cost

Certification Bodies offer ISO 13485 certification. 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.

 

REQUEST A QUOTE FOR ISO 13845 CERTIFICATION

Get a detailed quote of Get ISO 13485 Certification with a statement of work with a clear explanation of consultants and client responsibilities.