Post-approval services for your approved product

BIOREG will undertake registration renewals or change of registrations in a timely and cost-effective way.

How we approach Post-approval Consulting

At BIOREG, we fully appreciate that the successful registration of your product is just the beginning. Our team works hard to provide on-going protection for your investment advising on all of the scientific controls required for the maintenance and utilization of a product’s approval.

BIOREG will undertake registration renewals or change of registrations in a timely and cost-effective way.

BIOREG advises on regulatory maintenance, post-market surveillance (PMS) programs and clinical evaluation reports (CER).

We will review your current PMS programs or CER and provide a gap analysis. You can then decide whether you have the capacity to fill the gap using your own manpower or whether you would like us to provide a quote to perform this task on your behalf.

Post-approval support may be budgeted in a flexible manner which can includes hourly, per-project or retainer options.

What is Clinical Evaluation report (CER)

Clinical Evaluation Report should clearly outline the conclusions reached about the safety and performance of the device from the clinical evaluation, with respect to the intended use of the device. You should state whether the clinical evidence demonstrates conformity with relevant Essential Requirements, that performance and safety of the device as claimed have been established and finally, that risks associated with the use of the device are acceptable when weighed against the benefits to the patient.

What is a Clinical Evaluation?

Clinical evaluation is a methodologically sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device.

It ensures that the evaluation of safety and performance of the device is based on sufficient clinical evidence throughout the lifetime of the medical device on the market.

Clinical evaluation is a responsibility of the manufacturer and its requirements apply to all classes of medical devices in EU. However, the clinical evaluation should be appropriate to the device under evaluation, its risks, properties and its intended purpose. This process is mandatory for initial CE-marking and must be actively updated thereafter throughout the life-cycle of the product.

Clinical evaluation process includes the following steps:

  • Identification of the general safety and performance requirements that require support from relevant clinical data;
  • Identification of the available clinical data relevant to the device and its intended use generated through scientific literature search, clinical experience and/or clinical investigations;
  • Appraisal of the clinical data sets by evaluating their suitability for establishing the safety and performance of the device;
  • Creation of any new or additional clinical data needed to address outstanding issues;
  • Analysis of all relevant clinical data to reach conclusions about the safety and performance of the device.

CONTACT US

In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.

REGULATORY PACKAGES FOR STARTUP COMPANIES

We have created several packages for startup companies that will help you in every step of regulation process for your medical device or other medical product.

What Is Post Market Surveillance (PMS)?

Post Market Surveillance include all planned activities carried out by the manufacturers to institute and keep up to date a systematic procedure to proactively collect and review experience gained from their devices placed on the market, made available or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.

PMS system routinely monitors the clinical performance and clinical safety of the device. As for clinical evaluation, the scope and nature of PMS should be appropriate to the device and its intended purpose. New data generated through PMS process should be fed into the clinical evaluation process in a timely manner.

While clinical evaluation requires data from PMS activities, it also generates new information that have to be fed into the PMS and risk management process.

Use PMS Activities to Boost Your Marketing Goals

Data gathered by the manufacturer’s PMS system shall be used to update: risk-benefit (management) determination; design and manufacturing information, IFU and labelling and clinical evaluation.

PMS should identify needs for preventive or corrective action, possibilities to improve usability, performance and safety, whether existing claims are still justified and whether new claims could be justified.

Post-approval support may be budgeted in a flexible manner which can includes hourly, per-project or retainer options.

Get in touch to find out more about the Post-Approval services we can provide!