Consultancy 2019-10-10T09:59:06+01:00

Consultancy

From the internal knowledge of the processes and regulation, we support our clients in their new challenges with the aim of speeding up the entry in the market of their products. We provide technical, regulatory and quality support to all the stages of the product:

Study and analisis of the project:

  • Evaluate the class of product and define the regulations to apply.

  • Establish the conditions and manufacturing processes.

  • Diversification of existing manufacturing plants.

consultoría imasmed

Consultancy:

  • Comply with local and international regulations.

  • Implementation of GMP quality control systems – ISO 13485.

Regulation application:

  • Preparation for inspections of the health authorities.

  • CE marking.

  • Support in the application with the Notified Body.

Advice and support:

  • Risk analysis.

  • Systems qualification and validation.

Trainning:

  • Implementation of quality control system-GMP.

  • ISO 13485.

  • Regulatory affairs

Audit:

  • Audit to suppliers (homologation)

  • Audit for internal evaluation to comply with regulation ISO 13485