- Preparing, creating documentation and supporting during health authority, notified body and client audits, including product audits, quality system audits, etc.
- Support in resolving non-compliance detected during the audit process, by guiding towards a resolution, preparing supporting technical documentation, etc.
- Carrying out internal audits and external audits of critical suppliers nationally and internationally:
Documentation: reviewing the documentation required under ISO 13485
– Quality Manual.
– Procedures and records.
– Operation and process flow diagrams.
– Work instructions.
– Quality plans (policy, training, validation, calibration, etc.).
Facilities: on-site review of facilities to assess compliance with the standard.
Contacting and applying for procedures with health authorities (AEMPS, FDA, COFEPRIS, INVIMA, etc.) and notified bodies.
Training on regulations, guides, standards, ISOs, etc., related to medical devices.
Product viability evaluation
- Preliminary evaluation of products(s), defining market strategy, advice on trials and finding the most appropriate claim for correct classification and processing according to the current regulations.
Biocompatibility assessment report
- Researching bibliographies and reviewing articles, as well as preparing the biological evaluation report (BER) in accordance with ISO 10993-1:2018
Clinical evaluation by bibliography
- Evaluating scientific publications: searching various databases for publications on equivalent products and for the same claim, which have data relating to the performance and safety of these products.
- Preparing the clinical evaluation report in accordance with the recommendations of MEDDEV guide. 2.7.1 Rev.4 June 2016
Advice on regulatory compliance with trials
- Preclinical trials in accordance with ISO 10993 for the biocompatability assessment of medical devices.
- Clinical trials in accordance with Good Clinical Practices (ICH Topic E6, CPMP/ICH/135/95 and Parliament and Council Guidelines 2001/20/EC) and MEDDEV guide 2.7.1 Rev.