Manufacturing
We turn the materials we research into products ourselves.
Manufacturing
Medical devices and cosmetics
under one roof
Medical devices and cosmetics fall under different laws. They demand different standards and different records. ROSE LAB holds both systems and runs them in a single facility.
Principles
What we hold to
We make it ourselves
The medical device manufacturing facility was completed in 2021 and certified for manufacturing and quality control the following year. Because nothing is outsourced, the company knows exactly what was made and how.
Two laws, one principle
ISO 13485 for medical devices, ISO 22716 for cosmetics. The regulations differ; the principle does not. We do not lower the standard because a product is a cosmetic.
We keep the record
Every stage from incoming material to outgoing product is documented. Only when a problem can be traced back to where it began does the word control mean anything.
Kept by audit
A certificate matters not on the day it is issued but for as long as it is kept. Both the ISO standards and GMP are maintained through periodic audit.
Process
Quality control
Control is not inspecting the result; it is deciding the process in advance. From the moment material arrives to the moment product leaves, each stage has a standard and a record.
Incoming material
Only material meeting specification is accepted. Test results are checked and the history recorded.
In-process control
Made under set conditions, in a set order. Outside those conditions, the line stops.
Finished product testing
Conformity is confirmed before release. What does not pass does not ship.
Traceability
Records let any lot number be traced back to its raw material.
Standards
Quality system certifications
Certification does not end on the day it is granted. It is held only by passing periodic audit.
| Certification | Scope | Obtained |
|---|---|---|
| Medical device GMP | Conformity with medical device manufacturing and quality control standards | 2022 |
| ISO 13485 | Medical device quality management system | 2022 |
| ISO 9001 | Quality management system | 2023 |
| ISO 22716 | Cosmetics good manufacturing practice | 2023 |
| Inno-Biz | Technology innovation SME certification | 2023 |
| Venture Business | R&D enterprise (Korea Technology Finance Corp.) | 2020 |
Licences
Licences and registrations
- Medical device manufacturing licence
- 2016
- Corporate research institute established
- 2016
- Export medical device product licence (tissue restoration biomaterial)
- 2017
- Cosmetics responsible distributor registration
- 2017
- Cosmetics manufacturing registration
- 2023
We are looking for partners
We welcome distribution, partnership and product enquiries.