More services

510k
We provide 510k Medical Device (MD) consulting services to medical device companies in Israel. Our services are available for specific projects or individual tasks. We can assist your team with 510k preparation, review, determination of appropriate corrective actions and deciding how to best comply with FDA marketing clearance requirements.
We can also identify appropriate suppliers, develop needed processes and help your company ensure overall quality and regulatory compliance. From MD product development to post market surveillance, our MD consulting services help your business navigate the quality and regulatory compliance process. MD startup or small business clients are also welcomed!
• We offer effective FDA regulatory support for all sizes of firms, from small, start-ups to large, multi-divisional companies.
• Our FDA consulting services are fully tailored to address your particular business needs.
• Our FDA consulting and project management services are always within your budget.
• We maintain constant accessibility and support both on- and off-site during the course of your FDA consulting project.
CE marking
We are ready to fully support your CE Marking transition from the Medical Devices Directive (MDD) to the Medical Devices Regulation (MDR).
• EU MDR 2017/745 Gap Assessment and CE Transition Strategy for MD Manufacturers.
• Strategy planning and finance consulting.
• EU MDR Training.
• Health Canada submissions.
• MEDDEV 2.7.1 rev 4 and Clinical Evaluation Reports (CER) for MD. Literature review.
What is to be done:
Before the CE Mark may be affixed to a MD and legally sold within the EU:
• Classify MD per the classification rules: Annex VIII, MDR
• Prepare Medical Device File (MDF) to show MD compliance with applicable General Safety and Performance Requirements (GSPR MDR Annex I)
• Establish a monitoring system – Vigilance, etc. and an accident reporting system.
• Issue a Declaration of Conformity (DoC).
• Register with the European Representative and the appropriate Competent Authorities
• Receive a CE Certificate from the Notified Body (NB)
ISO 13485 and ISO 9001
Quality Management System (QMS) Compliance:
We make sure a QMS that your Company meets the QMS specifications and requirements through:
• Establishment and implementation of the QMS
• Issuing and maintaining of the Quality Manual and Standard Operation Procedures (SOP)
• Establish MRB, CAPA, Training, Labeling, Document Control and Internal Audit systems
• Clean Rooms, Sterilization, Packaging & Transportation validations
• Gap Analysis – assessment of your compliance with the current applicable requirements
Auditing
Audits are executed to determine regulatory compliance and improve effectivity of your processes and those of your critical subcontractors and suppliers
• Internal Audit – Essential to continuously improve your process and to regulatory compliance.
• Subcontractor / Supplier Audit – vital to your QMS
• CE Pre-Audit – to guide you through the audit process before the NB appears
• Unannounced Audit by NB
• We offer on-site support during regulatory audits or regulatory inspections.
Sterilization Validation / Microbiology
Validation of sterilization and control of microbiological contamination are of paramount importance to ensuring MD safety and preventing infection.
We have the expertise to perform sterilization validation studies using Gamma, or Steam per ANSI, AAMI, and ISO 11135, 11137, and 17665 standards. We can review your microbiology processes for regulatory compliance, including environmental monitoring and clean room evaluations, bioburden monitoring and trending programs, package shelf life evaluations; and steam sterilization validations.
Microbiology Process Evaluation
Environmental control is a requirement of all Good Manufacturing Practices (GMP). Monitoring, trending, and ongoing evaluations are key to microbiological control. We can help design and optimize your clean room evaluations and sterilizer validations. Our expertise includes:
• Environmental monitoring
• Bioburden monitoring
• Trending programs
• Clean room evaluations
• Steam sterilizer validation
Outsourcing
RA and QA outsourcing will help you increase productivity, streamline processes, achieve efficiency and save money. This service includes:
• Temporary full-time, part-time, or “as needed” consulting for QMS compliance and RA.
• Preparation of global regulatory submissions, 510k, MDF, Health Canada, etc…
• Audits of your or a supplier’s QMS.
• Implement CAPA.
• Supporting quality metrics and analysis as part of the management review meetings.
• Internal audit training, risk management, QMS, other training needs.
• Complaint handling, contract review, and surveillance audits.
• Document control and maintenance of the QMS.