Quality Services

1MED provides support with your Quality Management System creation, implementation and maintenance.​

In order to bring products to the market, it is mandatory for manufacturers to have a Quality Management System (QMS) in place. 1MED supports your Company with the creation of your ISO 13485 compliant QMS and/or ensuring its maintenance. ​​​​​​​
New MDR has formalized the expectations that your QMS documents, records, product information, risk, etc. are all connected together. In other words, all documentation and records of your QMS and products need to be a seamless system of data and information, and 1MED supports you in making this requirement a reality in your Company.

We can support you for the following quality activities:

   ISO 13485 QMS

  • Implementation and maintenance of your QMS
  • Quality documentation review and Gap Analysis
  • CA/PA support
  • Internal audits
  • Suppliers’ qualification
  • Support during Notified Body audits

 

All Companies should have within their quality system a defined strategy for regulatory compliance. However, while being ISO 13485:2016 certified is important, this does not ensure that your QMS is harmonized with the MDR and its requirements.

  The MDR has introduced some additional QMS expectations with respect to:

  • Post-market Surveillance (PMS)
  • Periodic Safety Update Report (PSUR)
  • Incidents and Field Safety Corrective Actions (FSCA)
  • Resource Management / Supply Chain
  • UDI and Labeling
  • Regulatory Compliance
  • Document Storage Retention
  • General Safety and Performance Requirements (GSPR)
  • Implantable Devices
  • Clinical Evidence
  • Economic Operators
  • EUDAMED database

 

Quality Services

1MED provides support with your Quality Management System creation, implementation and maintenance.​

In order to bring products to the market, it is mandatory for manufacturers to have a Quality Management System (QMS) in place. 1MED supports your Company with the creation of your ISO 13485 compliant QMS and/or ensuring its maintenance. ​​​​​​​
New MDR has formalized the expectations that your QMS documents, records, product information, risk, etc. are all connected together. In other words, all documentation and records of your QMS and products need to be a seamless system of data and information, and 1MED supports you in making this requirement a reality in your Company.

We can support you for the following quality activities:

   ISO 13485 QMS

  • Implementation and maintenance of your QMS
  • Quality documentation review and Gap Analysis
  • CA/PA support
  • Internal audits
  • Suppliers’ qualification
  • Support during Notified Body audits

 

All Companies should have within their quality system a defined strategy for regulatory compliance. However, while being ISO 13485:2016 certified is important, this does not ensure that your QMS is harmonized with the MDR and its requirements.

  The MDR has introduced some  additional QMS expectations with respect to:

  • Post-market Surveillance (PMS)
  • Periodic Safety Update Report (PSUR)
  • Incidents and Field Safety Corrective Actions (FSCA)
  • Resource Management / Supply Chain
  • UDI and Labeling
  • Regulatory Compliance
  • Document Storage Retention
  • General Safety and Performance Requirements (GSPR)
  • Implantable Devices
  • Clinical Evidence
  • Economic Operators
  • EUDAMED database

 

REGULATION (EU) 2017/745

REGULATION (EU) 2017/745