Medical Devices
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
- Product classification
- Regulatory strategy
- Clinical strategy
Design & Development
- Quality plan and design input
- Design output
- Validation and verification
- Preclinical and clinical trials
Marketing
- Regulatory submission clearance & approval
- Transfer to production
- Post market activities
Regulatory and V&V
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(QMS)
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)
Clinical
We offer clinical strategy development, medical writing, submissions, and clinical trial initiation, execution and monitoring, data management, auditing, training, and project management.
Validation
▪ 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
Audits
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
FDA
Approval process:
●Registration
●510(k)
●PMA
●De-NovoOur services include registration, writing pre-submission and submission files, communication with the FDA, and preparation for FDA audits as necessary.
Europe
CE
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).
APPLICABLE STANDARDS
customers
NEWS & ARTICLES
OUR CUSTOMERS SAY
"I would like to thank you for your hard work and dedication to this project. Your good spirit and enthusiasm created a good collaboration between Gsap and Biosense and in the end, it is what brought us to the finish-line on time, with the desired outcome. You have definitely left your mark on our processes and we will benefit from your work for years to come. We still have a bit of work to do before we wrap up this project, but thanks to you we will complete the project on time. It was a pleasure working with you all. See you all on our next project"
Biosense Webster
"At the end of a very successful audit, I would like to thank you on behalf of myself, the whole company, and all of our patients. You have taken on a difficult task, with a tight schedule and extraordinary conditions. We were very impressed with the immediate commitment to the effort, dedication and professional ability to discern what to do immediately and what required a postponement to a more relaxed time. The management of the assessment itself was also excellent and was conducted calmly and professionally. The wonderful result of all the effort is beyond our expectations! "
Apifix
"We would like to thank the Gsap team for their dedication, investment and sharpness, which contributed to our successful audit! You're already part of the family! "
Syqe Medical