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Company Organization in the New Pharmaceutical Quality System

We can help you improve the efficiency of your quality systems. Strategic planning guarantees security in the achievement of the intended objectives, always in a controlled manner, and helps you prioritize the allocation of resources.
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ISO 13485

Quality System based on ISO 13485:2016

We can provide consultancy and technical assistance for the development of the Quality Management System (QMS) based on ISO 13485 for the design, development and commercialization of Medical Devices.
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Technical File Update

In-Vitro Diagnostics (IVD) Products Technical File Update

Our medical device experts can assist your company in order to foresee the Technical File chapters you may need to update for the new IVD Regulation compliance. We can assist you in the preparation of the Technical File that will be reviewed by the Notified Body and also in updating your QMS so that it is compliant with the new regulation.
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Implementing Data Integrity in a Pharmaceutical Company

We can help you to efficiently establish a system with a cyclical approach, solid design, based on principles of risk management and in full compliance with current Data Integrity regulations. Our team of experts will guide and advise you throughout the process, ensuring that we create the bases to disseminate the culture of Data Integrity within your organization.
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Mock inspection

Medical Devices Mock Inspection

We are capable of professionally carrying out mock inspections based on the specific regulatory requirements in order to identify the improvement needs. Our experts will define a project plan according to the objectives and provide external support (providing resources and expertise). We understand your company’s goals and will adjust the priority tasks accordingly, with the goal to drive your organization to full compliance.
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Validation of Software as a Medical Device (SaMD) for Diagnostic

We have a huge experience in software validation. We can assess your company to define the best approach to assure that your SaMD is compliant with Medical Device regulations.
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GDP Implementation

GDP Implementation in a Logistics Company

A GDP implementation project with our consultants will allow you meeting the standards and requirements established in the current guidelines. Our risk based approach strategy will allow optimizing your processes in order to achieve compliance without a major impact in your organization.
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CE Mark

CE Mark for a Software as a Medical Device (SaMD)

We can assist your company in the EU CE Marking (even according to the new EU Regulation; Medical Devices Regulation (EU) 2017/745 or in Vitro Diagnostic Devices Regulation (EU) 2017/746). Our Medical Devices team will establish the optimal approach to guide and advise you to obtain the CE Mark (self-certification or by an authorized Notified Body) and also to implement a Quality Management System according to ISO 13485:2016.
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