What are Clinical Evaluations and how they may affect your business?

A Clinical Evaluation is an assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer. A Clinical Evaluation is required for all medical devices to be marketed in Europe. Alternative treatment options including no treatment should be […]

MDD (Medical Device Directive) and Medical Device Regulation (MDR) Transitional Provisions

If you have CE marked products in Europe, you may already be aware of the change from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR).  Currently, the MDD is no longer but if you have products that are CE marked under the MDD, Article 120 of the MDR may allow you to […]

Which Standard should I use?

The prefix of the standard provides clues as to which country it originates from. For example, ASTM stands for American Society for Testing and Materials and ANSI stands for American National Standards Institute. ASTM and ANSI are typically used in the United States. ISO, which stands for International Standard Organization, defines many standards which are […]

Quality Management System: Employee Roles

If you are creating or in an organization, the question of what “role” each employee plays will come up. Naturally, we think of assigned titles such as “President”, “CEO”, “Founder”, “CTO” as a person’s assigned role. But do people with these assigned titles truly understand what their responsibilities in their role really means? In a […]

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