Regarding support for field surveys
Updated: July 2024, 9
What is a field survey?
On-site inspections are unavoidable when applying for medical device permits.
An on-site inspection is an investigation to confirm whether the manufacturing control or quality control methods at the manufacturing site comply with the QMS ministerial ordinance. The person undergoing the investigation must understand each ministerial ordinance and the procedures based on it.
Even after product approval, periodic investigations are required.
concrete flow
Contents of support
① We support the creation of various procedure manuals.
When undergoing on-site inspections, we refer to ministerial ordinances based on quality and safety, and conduct inspections in accordance with our products.GVP Safety Management Business Regulations(about 50 pages),Quality manual(about 40 pages),Each regulation(150 pages)three documentsneed to be aligned.
At our company, each customerCustomize the template international success.
It is quite difficult to create a template from scratch, so by supporting us, you can apply for a permit more efficiently.
②We will give a lecture on the QMS procedure manual in preparation for the field survey.
In preparation for the field survey, we will hold lectures several times to deepen your understanding of the content.
③ Attend the field survey.
We will be present during the on-site inspection to alleviate customer concerns.
④We will provide support from a long-term perspective.
We can assist you not only with permit applications and certification, but also with renewals after five years, so we can provide advice from a long-term perspective.
Benefits
- Fast and reliable response
Our motto is speed. We provide prompt and reliable support.
- Efficient and smooth application
You can focus on "what your company should be doing" without spending time and effort on creating specialized and complex documents.
- long term support
In addition to preparing the necessary documents, we provide long-term consulting on the process until permission is granted, including holding study sessions for on-site inspections and accompanying you on the day.
- Nationwide support
Available anywhere in the country.
- Multilingual support
It supports English, Chinese, and Korean.
