our services
our services
We have group of experienced independent professionals and specialists in each product category to provide strategic advice.
CONSULTING
Consulting on quality management standards and product standards
Quality Management System
ISO 13485 (Quality Management System for Medical Devices: QMS-MD)
MDSAP (The MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.)
ISO 9001 (Quality Management System: QMS)
ISO 14001 (Environmental Management System: EMS)
GHP (Good Hygiene Practice) and HACCP (Hazard Analysis and Critical Control Point)
ISO/IEC 17025 (General Requirements for the Competence of Testing and Calibration Laboratories)
Other
ISO 13485 (Quality Management System for Medical Devices: QMS-MD)
MDSAP (The MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.)
ISO 9001 (Quality Management System: QMS)
ISO 14001 (Environmental Management System: EMS)
GHP (Good Hygiene Practice) and HACCP (Hazard Analysis and Critical Control Point)
ISO/IEC 17025 (General Requirements for the Competence of Testing and Calibration Laboratories)
Other
Registration
Thailand Registration of Medical Device
Manufacturer establishment - Service fee
Import establishment - Service fee
Seller's License (Specific product*)- Service fee
New Product registration/Medical Device License – CSDT for class 1/2/3/4
Manufacturer establishment - Service fee
Import establishment - Service fee
Seller's License (Specific product*)- Service fee
New Product registration/Medical Device License – CSDT for class 1/2/3/4
The European Union Medical Device Regulation
MDR Technical document (EU MDR 2017/745) – Class I, Is/r/m, IIa, IIb and III
EU representative - Global Partners
Registration – Global Partners
Contact/Liaise with EU Authorized Representative on behalf of Product Owner/Manufacturer
EU PRRC (Person Responsible for Regulatory Compliance)
PPE Technical document (EU PPE 2016/425) – category 1/2/3
QMS for EU MDR
EUDAMED registration (SRN number)
EU Adverse Event Reporting
MDR Technical document (EU MDR 2017/745) – Class I, Is/r/m, IIa, IIb and III
EU representative - Global Partners
Registration – Global Partners
Contact/Liaise with EU Authorized Representative on behalf of Product Owner/Manufacturer
EU PRRC (Person Responsible for Regulatory Compliance)
PPE Technical document (EU PPE 2016/425) – category 1/2/3
QMS for EU MDR
EUDAMED registration (SRN number)
EU Adverse Event Reporting
The Medicines and Healthcare Products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
UK Responsible Person (UK RP) - Global Partners
MHRA registration - Global Partners
Technical document
PPE Technical document (PPE 2016/425 and enforcement regulations2018) – category 1/2/3
UK Responsible Person (UK RP) - Global Partners
MHRA registration - Global Partners
Technical document
PPE Technical document (PPE 2016/425 and enforcement regulations2018) – category 1/2/3
U.S. Food and Drug Administration
FDA Establishment – Global Partners
510(k) documents and submission
Small business certification
FDA Medical Device Reporting
FDA Warning Letter Resolution
FDA Establishment – Global Partners
510(k) documents and submission
Small business certification
FDA Medical Device Reporting
FDA Warning Letter Resolution
TRAINING
In-house Training
You can choose the training format, either Online or On-site, or both formats at once.
Select standards as you need to training
You can choose the training format, either Online or On-site, or both formats at once.
Select standards as you need to training