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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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