Regulatory Affairs

(Pre-) Clinical Strategies

genae can develop an overall Regulatory and Clinical Strategy for your medical device and translate it into a feasible clinical study protocol. Working with your team, we will help you design a clinical study to meet regulatory requirements keeping in mind your specific needs including optimal data measurements to support your product claims.

Regulatory Due Diligence

genae conducts thorough reviews of the regulatory status of companies for projects or prospective acquisitions to provide comprehensive information to potential investors. By working with us, our clients can benefit from our specialist knowledge and experience in both Regulatory Affairs and the Medical Device market, our broad spectrum of expertise results in a clear view associated opportunities and risks and options for mitigation. The Regulatory Due Diligence is usually conducted in cooperation with legal, financial, and insurance advisors appointed by the client.

Regulatory approval process

genae can assist you with services such as identification of the device classification, determining the most suitable route to conformity, authorized representation, technical file review and Risk Management Plan development in accordance with the ISO14971, ISO13485 and the FDA QSR.

Market Access and Reimbursement Strategy

Let genae set up the optimal strategy to access your device market. Our combined global view and local expertise will help you enter new markets quickly and cost effectively. While qualifying your medical device for reimbursement can be a long process, we can help you every step of the way:

• define the reimbursement class
• set up a strategy to obtain the highest level of reimbursement
• define the steps needed to navigate you through the process

genae can help you to enter new markets quickly and cost-effectively.

Authorized or Legal representation

Authorized or Legal representation is required when manufacturing or marketing in various regions of the world:

• The United States FDA requires all medical device and IVD companies without a presence in the US, to appoint a registered US FDA Agent. The US FDA Agent must be a USA resident or maintain a physical place of business in the US and serves as a liaison between your company and the FDA.
• The European Union requires all foreign firms wishing to market medical devices in the EU to appoint an Authorized Representative (AR) to represent the manufacturer in all European Regulatory Affairs, including registration, labeling, IFU and more.
• The Medical Device Division of the Israeli Ministry of Health (AMAR) requires all medical devices manufactured or marketed in Israel to be registered by the Ministry of Health registrar. Applications for registration shall be done only by an Israeli citizen or by a corporate established in Israel.

genae can act as your local representation in the US, Europe and Israel (via the acquired MedicSense) in case you do not have local presence in this geographic area. We support your regulatory compliance and approval process by acting as your independent legal and/or authorized representative.

Benefit-Risk Assessment (FDA)

In the US, the testing of a device's safety, effectiveness, and quality is regulated by stringent regulations of the FDA. genae has profound knowledge of these regulations and can provide insight on risk mitigation and clinical benefits of investigational devices.

Clinical Evaluation Report (CER)

Our regulatory team has the experience and knowledge to perform and document clinical evaluations. Our experts can assist you with designing a new Clinical Evaluation Report (CER) or updating an existing one and are fully equipped to conduct a gap analysis between your CERs and the most current European requirements (as published in the MDR).

Medical writing

Medical and regulatory documentation developed by experienced medical writing teams plays a pivotal role in the success of a clinical research project. Our professional service encompassing all regulatory requirements will be tailored to your needs. Our medical writing team works closely with key operational departments including Biostatistics, Medical Affairs, Quality Assurance, Regulatory and Clinical Operations to access a fully integrated network of information.