Advisory + Staffing Services

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Reliant Life Sciences

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Reliant Life Sciences

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Send us a message to connect with an expert regarding our advisory and staffing capabilities. Don’t worry, we’ll never spam you.

Consultant Opportunities

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Reliant Life Sciences

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Complete the following form and our team will email you opportunities that match your skills and interests. Don’t worry, we’ll never spam you.

Advisory + Staffing Services

Schedule a Consultation
Reliant Life Sciences

Schedule a Consultation

Schedule a few minutes to connect with an expert regarding your project’s advisory and/or staffing needs. Don’t worry, we’ll never spam you.

Send a Message
Reliant Life Sciences

Send a Message

Send us a message to connect with an expert regarding our advisory and staffing capabilities. Don’t worry, we’ll never spam you.

Consultant Opportunities

Connect with a Recruiter
Reliant Life Sciences

Connect with a Recruiter

Complete the following form to connect with a Reliant Life Sciences recruiter regarding opportunities that match your skills and interests. Don’t worry, we’ll never spam you.

Sign-up for Job Alerts
Reliant Life Sciences

Sign-up for Job Alerts

Complete the following form and our team will email you opportunities that match your skills and interests. Don’t worry, we’ll never spam you.

Medical Device Regulations

As of May 26th 2021, Medical Devices companies that want to sell their products in the European marketplace will have to comply with the new EU Medical Device Regulations (MDR), which is a new set of regulations governing the production and distribution of medical devices in Europe.

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Reliant Life Sciences

Schedule a Consultation

Schedule a few minutes to connect with an expert regarding your project’s advisory and/or staffing needs. Don’t worry, we’ll never spam you.

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Reliant Life Sciences

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Send us a message to connect with an expert regarding our advisory and staffing capabilities. Don’t worry, we’ll never spam you.

Several devices not covered by the previous Medical Device Directive (MDD) requirements now fall under the MDR requirements, and in many cases, the devices need to be re-classified.

MDR will replace the existing Medical Device Directive (92/42/EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD).

The main reason for MDR is to ensure high standards of quality and safety for medical devices being produced in or supplied into Europe.

The regulation holds amongst other several new requirements that must be adhered to:

  • Even for Class I devices, an ISO 13485:2016 compliant Quality Management System (QMS) is now required.
  • New Medical Device Classifications and system supported by the Conformity Assessment
  • Registration and communication related to the Authorized Notified Body with an agreed mandate
  • Registration in the European database on medical devices (EUDAMED)
  • Labelling (CE) and UDI (Unique Device Identification) documentation and maintenance.
  • Post-Market activities, such as implementing a surveillance system and a system for reporting incidents and safety corrective actions.

Reliant can offer a scalable turn-key solution and services that will support and enable startups, spinoffs, small and medium-sized medical device companies to comply with the new regulations listed above.  We are ready to support the new quality and regulatory requirements that must be met throughout the medical device lifecycle.