Life Sciences Consulting

Technical File Compilation

Every manufacturer of medical devices must demonstrate product compliance with applicable MDD essential requirements in order to CE mark his product. This is accomplished by designating the documents demonstrating compliance with each essential requirement.

Gidac has profound knowledge in compiling MDD technical files from the initial requirement specifications to the final declaration of conformity.

Strategic Considerations

By identifying the optimal regulatory strategies for your product at an early stage, costly pitfalls can be evaded saving significant amount of time and costs. By carefully defining the intended purpose of your product you may achieve a lower MDD classification and reduce the verification and validation required to demonstrate product compliance with applicable essential requirements and thereby significantly reduce time-to-market.

Regulatory strategies for novel medical devices and drug/device combinational products is a core competence of Gidac.

Risk Management

The patient risks of your product should be identified and mitigated prior to or early in the product development. Mitigating risks by re-design of a product in a late stage of development or even released to market is a costly and time-consuming activity.

Gidac has the experience to guide you through the entire risk management of your product.

Supplier Evaluations

Inspect what you expect – If you omit examining your suppliers, the quality of your products and consequently the success of your products when launched to market is nothing but a lottery.

Gidac has the keen understanding to perform on-site supplier audits or document review– we know what to ask for.