返回Shenzhen Healthcare Electronic is a professional manufacturer specialising in producing various body fat scales and
electronic scales, the company has been in business for many years and has more than seven hundred employees.
It is one of the top three body fat scales in the industry.
Based on the cooperation of FDA factory inspection in 2014, the company continued to employ our company as a
consultant for this MDSAP certification.
The counselling was carried out by our general consultant, and after the contract was signed, both parties negotiated
a counselling plan.
We strictly followed the plan and implemented regulatory training, response requirements, document revision, model
provision and record auditing services for the client.
The audit was conducted by SGS 0120 and lasted for 7 days.
Accompanied by our general consultant, the client successfully passed the MDSAP certification audit based on good
counselling and preparation in the early stage and good on-site response ability. Up to now, this is the 9th enterprise
that has successfully passed the MDSAP certification under the counselling of our company.
At the end of the audit, the inspector declared that there were zero defects of level 4 and 5, and only 10 minor defects
of level 3 or below.
Among them, there were 5 problems due to human errors of the client company, such as the drawings were not
labelled with allowable errors, the electronic record list was not established, and the risk management of the PMS
collection results was not done according to the requirements, and so on.
The details and attention to detail of the overall MDSAP audit are much stricter than the FDA factory inspection, and
planning is a key task when preparing for MDSAP.
So companies that need to prepare for MDSAP certification must pay attention to choosing the right consulting firm.
