Our services

QUALITY SYSTEM

When manufacturing a Medical Device, you are required to establish, implement and maintain a Quality Management System (QMS) that complies with applicable regulatory requirements (such as ISO 13485, 21CFR 820, and MDSAP related regulations). 

This can be a challenging process, because your Quality System is not a set of independent documents but is indeed an ensemble of documented policies and procedures that define many interrelated processes, like design and development, production, change control, supplier management, corrective and preventive action (CAPA) and more.

After years of practice and thoughts, we developed an effective quality system that our QA experts will help you customize and implement in your organization, in order for you to have an effective QMS, that complies with the requirements and is continuously improved.

You already have a quality system? Our experts have the knowledge and experience in all processes and will support your system through all product life-cycle phases, including development, clinical trials, audits, and placing devices in the market.

MDSAP

You want to sell your device in Canada? The Medical Device Single Audit Program (MDSAP) is what you need. This program allows recognized Auditing Organizations (AOs) to conduct a single auditof your quality system to assess the compliance with the relevant regulation requirements of Canada and four other countries participate in the program: Australia, Brazil, Japan and US. 

We have the expertise and the experience to assist your organization with supporting and managing all activities toward obtaining the MDSAP certification, including choosing the right Auditing Organization for you, the establishment of a comprehensive gap analysis of your QMS processes, the implementation of all requirements within the quality system, the training of your employees, and the performance of internal audits. We can also lead your MDSAP audit and help you face the Auditing Organization. 

INTERNAL AUDITS

The production and quality systems of medical devices and IVD must be audited regularly, to verify compliance with the relevant regulatory requirements, ensure the patients and users safety and the product quality, and constantly improve processes within the company.

We have the expertise and experience to conduct internal audits of your quality system, design control, production aspects, and clinical files, for compliance with ISO 13485, the FDA QSR, the MDR 2017/745, the IVDR 2017/746, MDSAP requirements, and others.

We can also provide auditing services of contract manufacturers, subcontractors and/or suppliers, according to your needs and requirements.

E-QMS

When manufacturing a Medical Device, you are required to establish, implement and maintain a Quality Management System (QMS) that complies with applicable regulatory requirements (such as ISO 13485, 21CFR 820, and MDSAP related regulations). 

This can be a challenging process, because your Quality System is not a set of independent documents but is indeed an ensemble of documented policies and procedures that define many interrelated processes, like design and development, production, change control, supplier management, corrective and preventive action (CAPA) and more.

After years of practice and thoughts, we developed an effective quality system that our QA experts will help you customize and implement in your organization, in order for you to have an effective QMS, that complies with the requirements and is continuously improved.

You already have a quality system? Our experts have the knowledge and experience in all processes and will support your system through all product life-cycle phases, including development, clinical trials, audits, and placing devices in the market.

DESIGN CONTROL

We have to create a clear methodology to address and follow design control requirements during the development of new products, or when significant changes to existing products are implemented.
How hard can this be? Apparently not so easy, considering the different stages that must be distinguished from each other, the gates, the design reviews, the I/O Matrixes, etc., taking into consideration risk management processes and human factors engineering as well. And let’s not even go into how to verify design output meets design input requirements, or how validations are conducted to ensure design output meets user needs and intended uses.
We do know development teams are focused on the device, so we can assist in leading, training, overseeing, and guiding the teams to comply with the requirements so you do not need to work so hard when an audit is coming up.

RISK MANAGEMENT

Risk management process aims to identify potential risks and failures occurring throughout the device life cycle, evaluate and balance them against the benefits of the device, and to ensure that adequate actions are taken for preventing and/or reducing these risks as far as possible.
We can assist you to integrate risk processes into your design, to make sure you do not overlook important considerations and mitigations and make this process meaningful, and not just a paper exercise.

UDI

What is the UDI? This Unique Device Identifier (UDI) is a traceability tool, aimed at increasing patient safety and optimizing patient care by proposing tailored legislation by both the FDA and the European Commission (with exceptions). 

Our QA/RA experts will assist you in assessing the impact of the UDI implementation on your QMS processes, help you choose a designated Issuing Entity/Agency , support you with managing the UDI System for your products, register in the UDI database (GUDID, EUDAMED) and support you with implementing all requirements allowing you to sell your device on the territories you chose.

REGULATORY STRATEGY

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.

TARGETING THE US MARKET

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

MDR

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.

IVDR

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

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 EVALUATION

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.

CLINICAL DEVELOPMENT PLAN

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

PMS AND PMCF PLANS, PSUR

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.

AMAR

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. 

CRO

Our team has extensive experience spread across all trial categories from early-stage feasibility studies through later stage pilot & pivotal studies, to PMS studies, in various therapeutic areas.

We cover the span of the clinical research process and can provide you with full project management or modulated services, such as study design, site qualification, submissions, CRF design, monitoring, study plans (CIP), reports, clinical audits, etc., as applicable, according to the applicable regulatory requirements (such as ISO 14155, MDR and FDA CFRs).

CLINICAL INVESTIGATION AUDITS

The conduct of clinical investigation audits of Sponsors, clinical investigators, and investigation sites is essential to determine compliance with applicable agreements, sponsor procedures, EC requirements, the clinical investigation plan, Good Clinical Practice (GCP), IS0-14155 and where appropriate, national regulations. These audits may cover all involved parties, systems, processes, and facilities, and are independent of, and separate from quality control functions or routine monitoring.

Our clinical experts have the relevant required experience to perform clinical audits, as needed for your organization, to ensure and provide evidence that your clinical investigations are conducted in a manner that produces scientifically and medically valid data.

USABILITY/HUMAN FACTORS

A good Usability Engineering process, also called Human Factors Engineering (HFE), is helping you to ensure the safety of the use of your medical device for the patient, user, and others. During this process, we can identify and mitigate risks related to the interaction between the user and the device during its intended and foreseeable use.

This process consists of several phases, that are all integrated into the development of the design of your device. We have the expertise and the field experience to accompany you from the development phase, to identify the relevant specifications, analyze the risks, and create, organize, perform, and report custom-made formative and summative studies to demonstrate your user can safely use your device.