Regulatory affairs

A regulatory strategy is there to define your intended use and your product classification on the different markets you want to target. A good regulatory strategy will draw up the timelines and efforts needed for you to place your device on these markets. We will lay down the different routes you can use to be able to sell your product, as soon as possible.

More than that, a good regulatory strategy helps you explain to your investors the timelines and budgets you need before being able to sell your device, from the initiation of the project to the registration with the regulators. It will allow you to convince your board of which milestones are important and relevant to your company. In addition, it will avoid you overseeing an essential activity, going back and forth with the regulator, and it will let you choose the best strategy for your product and your company. It will also let you decide which market to target first, especially while Europe is still extending its transition period between the former directives and the MDR and IVDR regulations.

In the USA, the Food and Drugs Agency (FDA) is regulating all esthetic and medical devices. Your product is classified according to its risks as a Class I (low risk), Class II (medium risk), or Class III (high risk) device.

Before the marketing application, we can already start speaking with the FDA during a pre-submission meeting and avoid major surprises at the time of submission. During this pre-submission, we can define your regulatory pathway, verify the FDA agrees with your testing strategy, and gain some time and money by ensuring you will not have to repeat a usability, animal, or clinical study because the FDA disagreed with its protocol.
We will guide you during this process, help you prepare the documentation to send, and train you for this important meeting.

For the marketing application, we will also review your documentation, help you to improve it, and write and compile the appropriate submission package:

  • A 510(k) notification for your Class II device (or your Class I device in some specific cases)
  • A De Novo submission for your innovative low to medium risk device
  • A PMA package for your Class III device, or a PMA supplement when your device was already approved
  • A Humanitarian Device Exemption submission if your product is intended to benefit patients suffering from a rare condition

Following the implementation of the new MDR 2017/745 in Europe, we developed a thorough and effective plan to help you transition your QMS and your devices portfolio to the new requirements.

Our 8-step plan is developed over three phases, allowing you to identify the gaps, assess their impact, and implement processes to close them while successfully demonstrating compliance to your notified body.

In addition to providing you with this regulatory strategy and demonstrating compliance, we can help you with your clinical evaluation, your post-market surveillance (PMS and PMCF), and your whole technical documentation.

The new IVDR 2017/746, effective from May 2022 in Europe, represents a major shift in the regulatory framework on in vitro diagnostic medical devices. While under the previous directive (IVDD 98/79/EC) only devices detecting an analyte listed in the directive (List A and List B) or intended for self-testing were submitted to a conformity assessment by a notified body, the new regulation is classifying devices into four classes according to the risk for the patient or public health associated with their use. This significant change is fundamentally altering our landscape: while ~15% of devices were certified by 19 notified bodies, we are now in a situation where ~85% of devices need to be certified by only 8 notified bodies.

To address this, we developed a thorough and effective plan to help you implement or transition your QMS and your devices portfolio to the new requirements.

Our plan is developed over three phases, allowing you to identify the gaps, assess their impact, and implement processes to close them while successfully demonstrating compliance to your notified body.

In addition to providing you with this regulatory strategy and demonstrate compliance, we can help you with your performance evaluation, your post-market surveillance (PMS and PMPF), and your whole technical documentation, so you will be ready in 2025 (Class D devices), 2026 (Class C devices), or 2027 (Class B devices and Class A sterile devices).

Clinical Evaluation is a fundamental part of the development of your medical device, in which you are collecting, appraising and assessing all existing clinical data to demonstrate the safety and performance of your device, and its clinical benefits. This is an essential part of your technical documentation, and the cornerstone of the decision making of the notified body in certifying a new or an existing device. The CEP and CER are updated during the whole lifetime of the product with new clinical investigations and with Post Market Surveillance data collected by the company.

The Clinical Evaluation Plan is now needed to initiate a clinical investigation in Europe.

We have the expertise to define with you the best type of evaluation for your device. In addition, we can help you write the clinical evaluation, conduct the literature review, the analysis, the appraisal and the report of clinical data in your CER.

Biological safety is an essential requirement for all medical devices that will be in contact, direct or indirect, with the human body. The biological risk management process, defined in ISO 14971 and ISO 10993-1, is intimately connected to your design control: the evaluation is initially performed during the development of the device, and is then reviewed and updated any time a change of material, manufacturing process, or even supplier is performed.

Thanks to our expertise and our experience with all kinds of medical devices (from devices contacting the skin for few minutes to long term cardiovascular or brain implants), we can help you define precisely the category of your device, which biological endpoints you need to address, and the best way to address them, by using biological, chemical, or animal testing, or by drafting a scientifically sound rationale.

During this process, we will constantly address the dual risk related to the biological safety: the biological risk for your patient, and the regulatory risk for your device.

In line with Annex XIV Part A, a clinical development plan should be provided for the device that describes progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmatory investigations, such as pivotal clinical investigations, and a PMCF.

For legacy devices (and if applicable) please provide a justification within the clinical development plan for any deficiencies as described in the first indent noting any reference to PMCF activities that are ongoing or reference to the PMCF Plan as described in Annex XIV.
The clinical development plan should be part of the Clinical Evaluation Plan.

Please see a free template for a clinical development plan

You thought the hard work was completed once your device received regulatory approval and certification? Then think again.

Post-market surveillance (PMS) includes all activities carried out to proactively collect and review experience gained from devices on the field, including Post-market clinical follow-up (PMCF), such as surveys, user questionnaires, registries and literature analysis, etc.

With our expertise and our experience, we can guide and assist you with the stringent requirements for establishing a PMS procedure, defining PMS and PMCF plans and activities, ongoing collection and analysis of PMS data, and compiling comprehensive PMS reports, Periodic Safety Update Reports and PMCF Evaluation Reports that comply with the relevant regulatory guidelines.

If you want to sell your medical device in Israel, it must first be registered and approved by the Israeli Ministry of Health Medical Device Division (AMAR). 

For this registration, you will need an ISO 13485 certificate, a market approval for an accredited territory (such as a CE mark, an FDA clearance/approval, a Canadian certificate, etc.), and an Israeli Registration Holder if you’re not located in Israel.

Our QA/RA specialists can help you understanding regulatory requirements, prepare your submission, and support you at each step of the way.