Congratulations to HEALTHCARE for passing the MDSAP certification audit

Shenzhen Huisike Electronics is a professional manufacturer of various body fat scales and electronic scales. The company has been in operation for many years and currently has more than 700 employees. It is one of the top three body fat scales in the industry.

Based on the 2014 FDA factory inspection cooperation, the company has continued to hire our company as a consultant for the MDSAP certification.

This tutoring will be carried out by our company's general consultant. After the contract is signed, both parties will negotiate a consulting plan.
We strictly follow the plan and have implemented regulatory training, response requirements, document revisions, template provision, and record review services for our clients.

The issuing agency for this audit is SGS 0120, and the audit period is 7 audit days.
Our company's general consultant accompanied us throughout the entire audit process. Based on good guidance and preparation in the early stage, as well as excellent on-site response capabilities, we successfully passed the MDSAP certification audit. So far, this is the 9th enterprise that our company has successfully passed the MDSAP certification for coaching.

After the audit was completed, the inspector claimed that there were zero defects at levels four and five, with only 10 minor defects below level three.
Among them, there are 5 issues caused by human negligence of the client company, such as failure to indicate allowable errors on drawings, failure to establish an electronic record list, and failure to conduct risk management for PMS collection results as required.

The details and attention to detail of the overall audit of MDSAP are much stricter than FDA factory inspections, and planning is a key task when preparing MDSAP.
So for companies that need to prepare for MDSAP certification, they must pay attention to choosing a suitable consulting company.