Medical Devices

    Medical Devices

    Medical devices industry Gsap

    In the spirit of Gsap’s vision, the medical device section aims to bring safe, high quality products to patients in the shortest time possible

    Medical Devices LIFE CYCLE

    We are your partner from idea to market compliance!

    Planning of Product realization

    Planning of Product realization-medical d
    • Product classification
    • Regulatory strategy
    • Clinical strategy

    Design & Development

    • Quality plan and design input
    • Design output
    • Validation and verification
    • Preclinical and clinical trials


    • Regulatory submission clearance & approval
    • Transfer to production
    • Post market activities
    fda approved

    Regulatory and V&V

    Gsap provides extensive regulatory support from regulatory strategy development and submission to surveillance audits and liaison with FDA, Notified Bodies and other Competent Authorities. We work thoroughly and vigorously, incorporating a balanced business approach, to provide the most suitable and high-quality solutions for our clients.

    Our regulatory services include:

    ●Regulatory strategy & Regulatory plan including classification of medical devices (USA, EU, Israel, Canada, Australia, Brazil, Japan, WHO, and other markets).

    Consultation with medical devices regulatory authorities (FDA, Notified Bodies-NB, Competent Authorities-CA, AMAR).

    Registration of medical devices including UDI and labeling (Class I, Class IIa, Class IIb, Class III, Class A, Class B, Class C, Class D).

    Planning, Writing, and Review of Submissions and technical files of medical devices for FDA-510(k), FDA-De-Novo, FDA-PMA, EU-CE mark, Health Canada, AMAR, Canada, Australia, Brazil, Japan, and others.

    Product-related regulatory support and technical guidance for medical devices R&D processes including the implementation of suitable standards and testing, Product Verification and Validation (V&V) activities, and more.

    ●Supporting multifaceted V&V activities for medical devices including, Biocompatibility, Biological evaluation, Chemical characterization, Cleaning validation, Re-processing validation, Packaging, and shelf-life validation, Sterilization validation, Usability, and more.

    ●Implementation and periodic review of regulations, standards, and guidelines for medical devices (EU-MDD, EU-MDR, EU-IVD, EU-IVDR, 21CFR820, MDSAP, GMP, ISO13485, ISO14971, ISO10993, ISO14698, ISO14644, ISO14155, ISO11607, ISO60601, ISO62366, ISO11135, ISO11137, ISO17025, ISO15189).

    Implementation of the new European regulation for medical devices (EU-MDR 217/745) including an update of essential requirements to GSPR (General safety and performance requirements), EUDAMED, PMS (Post-marketing surveillance), PSUR (Periodic safety update report), PMCF (Post-marketing clinical follow up) and Vigilance.

    quality assurance medical


    Gsap establishes a culture for quality and improves quality system management (QMS). We develop, together with the client, a quality system that suits the organization and the product, both for clinical care and commercial applications, including all aspects required during the medical device life-cycle.

    We identify the requirements defined by regulatory authorities and international standards applicable to the specific medical device.

    Our Quality services include:

    ●Risk management (including FEMA and pFMEA)

    Product design & development

    Product verification and validation (V&V)

    Purchasing controls and acceptance sampling inspection

    Transfer to production

    ●Production & service control, including process capability control

    Process Verification and Validation

    Read more about process validation

    ●Control of measuring equipment

    ●Production, labeling, packaging, distribution

    ●Quality management reviews

    ●Non-conforming product (NC)

    ●Complaint handling

    ●Corrective and Preventive Action (CAPA)

    ●PMS (Post-marketing surveillance)

    ●PMCF (Post-marketing clinical follow-up)



    With a high level of expertise in clinical affairs, we support clinical trials for Class I, II and III medical devices, leading to high quality clinical data as per ISO14155 and ICH-GCP.

    We offer clinical strategy development, medical writing, submissions, and clinical trial initiation, execution and monitoring, data management, auditing, training, and project management.


    Our team will be your partner in all the aspects required for identifying the necessary process validation activities and guide you through process validation, according to the FDA, ISO 13485 and GHTF guidance.

    ▪ Risk analysis to define the process validation scope

    ▪ The Master Validation Plan (MVP)

    ▪ Plan and execute validation activities: IQ / TMV / OQ / PQ / PV

    ▪ Writing validation protocols, execution and writing validation reports.

    ▪ Develop and execute the Process Validation (PV)

    ▪ Statistical support in selecting sample size and results analysis


    Read more about process validation
    Read more about CSV 


    FDA audit


    Quality audits are required by medical device standards and regulations. Quality audits, when conducted in a professional manner, can have a great added value.

    Gsap provides a wide range of Internal and External audits and Site auditing. These audits are a necessary quality tool for meeting GMP requirements and authorizing suppliers, as well as for preparation for audits of the regulatory authorities (FDA, ISO, and more).

    Our Audits services include:

    Internal audits:

    Internal quality audits for evaluation of the QMS in accordance with ISO 9001

    Internal quality audits for evaluation of the QMS in accordance with ISO 13485

    Internal quality audits for evaluation of the QMS in accordance with MDSAP

    External audits:

    FDA mock audit

    Preparation for CE audits

    Custom-made audits according to customer’s request

    Global Submission

    Navigate your product development towards market compliance

    • USA


      Approval process:


      Our services include registration, writing pre-submission and submission files, communication with the FDA, and preparation for FDA audits as necessary.

    • Europe


      Gsap can help you to get your CE mark in Europe. Our services include writing and implementing QMS procedures, writing the technical documentation, and preparing for the notified body’s audit.

    • ISRAEL

      AMAR (MOH)

      Gsap can help you to get your approval in Israel. This includes the preparation of the necessary documentation and communication with AMAR in the Israeli Ministry of Health (MOH).