Mannheim-based Metecon GmbH has been supporting manufacturing companies in the medical technology sector for over 25 years and is a partner for all issues relating to regulatory compliance, increasing efficiency and adapting to dynamic market conditions. Three recent contributions from Metecon illustrate how the company contributes to the competitiveness and innovative strength of the industry with its solutions.

The perfect combination: RIM system and regulatory service provider

A Regulatory Information Management (RIM) system helps companies to automate and optimize regulatory processes. However, it is the combination with an experienced regulatory service provider such as Metecon that makes the decisive difference. The combination of technology, efficient data management and human expertise creates a future-proof compliance strategy. Manufacturers benefit from greater transparency, faster processes and increased regulatory certainty.
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Non-interventional studies (NIS): implementation, benefits and best practices

Non-interventional studies (NIS) are essential for post-market clinical follow-up (PMCF) and help to fulfill regulatory requirements according to MDR and ISO 14155. Metecon explains which criteria an NIS must fulfill, which ethical and legal aspects must be observed and how companies can use these studies efficiently. The revised version of an article from 2021 incorporates new findings from the field.
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Regulatory resilience: dealing with FDA uncertainties and EU challenges

The regulatory requirements for medical technology manufacturers are constantly changing. While the FDA is discussing deregulation in the USA, the hurdles to market access are increasing in the EU. In this article, Metecon shows why regulatory resilience - i.e. the ability to react flexibly to regulatory changes - is crucial for companies. The analysis of possible scenarios helps manufacturers to develop long-term strategies for different regulatory conditions.
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Metecon for the Health Innovation Network of Bayern Innovativ

With its solutions, Metecon makes a valuable contribution to the Health Innovation Network and strengthens the industry. The optimization of regulatory processes through RIM systems, the efficient implementation of clinical studies and the strategic handling of global market access conditions are key issues for medical technology companies. With strong partners such as Metecon, Bayern Innovativ can contribute to strengthening the innovative power and competitiveness of the industry in Bavaria through knowledge transfer and networking with companies with specialist expertise.