EU service
The way to MDR certification
proporcionado por nuestra filial TS Quality & Engineering
We provide comprehensive proposal for successfully achieving MDR certification.
Our Team of seasoned experts can provide support in all the following activities and deliverables:
- Technical Documentation as per Annex I, II and III of MDR
- Risk management process as per ISO 14971
- Usability process as per IEC 62366
- Clinical Evaluation according to Meddev, MDCG and MDR
- PMS, PMCF, SSCP, PSUR
- Software médico según la norma IEC 62304.
- Device master record
- Electronic IFU (e-IFU) smart solutions
- Medical device development
- MDSAP certification
- ISO 13485 certification and audit support
- Validación de procesos IQ, OQ, PQ
- Design control process remediation
- Person Responsible for Regulatory Compliance
- E-Learning
- Workshop onsite and remote
With same technical documentation, using our 3 locations,
El representante de su dispositivo médico no solo cumple con las normas, sino que también es eficiente.
It is challenging job for companies to arrange and liaison with three different entities to comply with the requirement in these territories.
Podemos ofrecer apoyo a los fabricantes para que designen representantes autorizados en Europa, Suiza y el Reino Unido.
AHORRE TIEMPO, CARGAS Y COSTOS
EU authorised representative
European Authorized Representative works as a connection between your company and the relevant national Competent Authorities (Ministries of Health) to ensure your compliance in Europe. Moreover, selected representative will make sure following:
- EUAR contributes with medical device registrations, as needed.
- La dirección EUAR debe figurar en la etiqueta del dispositivo.
- EUAR permite el registro en EUDAMED de empresas fuera de Europa.
- Los miembros de la EUAR deben mantener una copia actualizada del Expediente Técnico o la Declaración de Conformidad CE correspondiente, accesible para su inspección por una Autoridad Competente, según sea necesario.
- EUAR should support your company Vigilance activities with Incident and Field Safety Corrective Action (FSCA) reporting, in collaboration with the organization and its distributors
Representante autorizado suizo
Según el artículo 51 de la Ley suiza de Medicamentos (MedDo), el representante autorizado suizo debe prestar apoyo al fabricante en lo siguiente:
- Prove compliance with the registration obligations in Switzerland as per the revised MedDo.
- Prove compliance with MedDo’s device labeling requirements
- Giving access of the medical device’s samples to the Competent Authority.
- Cooperating with the Competent Authority to take any preventive or corrective action.
- Informar al fabricante sobre las quejas de pacientes, usuarios y profesionales sanitarios.
- Ensuring that Technical Documentation, EU Declaration of Conformity, and a relevant certificate is available for authority review
- Demonstrating device’s conformity by providing all the necessary documentation and information upon Competent Authority’s request.
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¿Qué podemos hacer por usted?
- Como su representante autorizado, le garantizamos el acceso al mercado suizo.
- Se ofrece a desempeñar el cargo de Persona Responsable del Cumplimiento Normativo (PRRC, por sus siglas en inglés) en Suiza.
- Le ayudamos a cumplir con los requisitos de etiquetado y los procedimientos de registro para el mercado suizo.
- Le brinda apoyo en el manejo de los comentarios del mercado y en su comunicación con las CA.
- cooperates with your regulatory affairs consultant
- supports you to obtain the Swiss Unique Identification Number “CHRN”
Persona responsable en el Reino Unido
MHRA requires non-UK medical device manufacturers willing to market their devices in the UK to appoint a UK representative based in the UK.
Under MHRA, the UK REP has to serve the following roles:
• Ensuring the availability of the documents as mentioned above and their certificates.
