We provide support with 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. 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. We support our clients in making this requirement a reality, helping to create an ISO 13485 QMS, implementing it and ensuring its maintenance.

Quality
Services

Quality
Services

We provide support with 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. 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. We support our clients in making this requirement a reality, helping to create an ISO 13485 QMS, implementing it and ensuring its maintenance.

We support for compliance with applicable requirements

While ISO 13485:2016 certification is important, it does not ensure that your QMS is harmonized with the MDR and its requirements.

The MDR has introduced some additional QMS expectations: we support you to reach compliance with new requirements for:

  • 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

We support for compliance with applicable requirements

While ISO 13485:2016 certification is important, it does not ensure that your QMS is harmonized with the MDR and its requirements.

The MDR has introduced some additional QMS expectations: we support you to reach compliance with new requirements for:

  • 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

We design and perform tailored training programs

Our Quality team is qualified by some of the most important Notified Bodies to support medtech companies in training activities within the Quality field, with focus on the ISO 13485 requirements related to the new European Medical Device Regulation (MDR) 2017/745.
We support our clients with tailor made on-site and off-site training programs that focus on company’s specific needs on MDR related quality aspects.

We 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
  • FDA 21 CFR part 820 – Quality System Regulation
Quality
Services

Quality Services

We design and perform tailored training programs

Our Quality team is qualified by some of the most important Notified Bodies to support medtech companies in training activities within the Quality field, with focus on the ISO 13485 requirements related to the new European Medical Device Regulation (MDR) 2017/745.
We support our clients with tailor made on-site and off-site training programs that focus on company’s specific needs on MDR related quality aspects.

We 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
  • FDA 21 CFR part 820 – Quality System Regulation