CUSTOMIZED SERVICES

Do you need help obtaining particular documentation as part of our full LICENSALE.COM® service or as an individual customized service? Arazy Group can help with that. We offer the following customized services:

MEDICAL DEVICE REGISTRATION

Application preparation, submission, and approval in 100 countries worldwide through LICENSALE.COM®, providing complete service throughout the product life cycle. Watch the video to learn more.

UNIVERSAL AUTHORIZED REPRESENTATIVE SERVICE

Many authorities require a local Authorized Representative, Designated Agent, or Marketing Authorized Holder, to act as the legal and regulatory contact with that body. Instead of surrendering control of your licenses to local distributors or multiple agents around the world, our Universal Authorized Representative service is available for you in over 100 countries worldwide under one contract, one currency, and one language. Since we hold your licenses for you, you retain control of your products around the world and independently from local distributors or other parties.

LICENSE MAINTENANCE

License maintenance, renewals, or transfers including annual reporting, periodic third-party inspections, audits, and updates to documents after product changes, as well as compliance with new regulations and product standards are included.

TECHNICAL VALIDATION AND LAB TESTING

Testing to demonstrate the safety, efficacy, or substantial equivalence of products is essential to the success of a license application. We provide the ability to manage and coordinate these testing requirements in addition to the following:

  • Electrical safety validation preparation and testing according to IEC 60601 series.
  • Material biocompatibility evaluation preparation and testing according to ISO 10993 and FDA guidance.
  • Software validation for medical device software (whether a stand-along device, a programmable component, or off-the-shelf-software), including training, online consulting, and/or third-party contracting throughout the product life-cycle (including traceability through changes and new versions and placement into validation protocol templates).
  • Preparation or implementation of Electromagnetic Compatibility (EMC) testing, (IEC 60601) including training, step-by-step guidance, on-site/online consulting, and/or full lab testing services.
  • Labeling design (including translation), preparation, review, or full technical writing service for product labeling, user manuals, and maintenance or calibration manuals.
  • Risk Analysis and risk management reporting training, step-by-step guidance, on-site or online consulting for compliance with ISO 14971.
  • Sterilization validation preparation, implementation, and third-party testing for sterility, bioburden trending, B&F, residuals, and adoption validations.
  • Packaging validation preparation, implementation, and third-party testing for package seal integrity and seal strength, shelf life, shipping and drop testing, and gas permeation or vacuum testing.

HUMAN FACTORS AND USABILITY VALIDATION

Human Factors/Usability testing focuses on Human Factors Engineering (HFE) as part of the design inputs. It is intended to lower the risk of misuse or mistakes when using the device based on human interaction and interfacing. Any potential hazards caused by the usage of the device across a broad range of user capabilities and environments should be identified and investigated throughout the product life-cycle through risk analysis and usability testing. Incorporating usability testing, which complies with international standards HE75, IEC 62366:2010, and USA FDA guidelines help a company prevent patient risk through misuse or unintended use of the device based on confusing interfaces or instructions for use.

  • Usability studies: Both formative studies and summative studies are available. Studies include training, identification of user groups, simulated environment, and include usability assessment of both the device and its labeling and user manuals.

CLINICAL EVALUATIONS

Clinical evaluations are now part of most regulatory submissions while higher risk devices are required to present their own clinical study data in their submission. Our team of experts is available to provide the following services according to international harmonized standards and national guidelines in one or more countries through training, step-by-step guidance, review examples, online consulting, and/or full third-party contracting for any type of medical or IVD devices.

  • Clinical Literature Review (CLR) reports to support product submissions and filings, including the weighing of articles, analysis of metrics, and an SE comparison when relevant.
  • Clinical development planning and trial design: Defining your clinical strategy and diligent planning can prevent project delays and budgetary deficits, optimize measured variables, and help ensure a well-defined patient population. Our team of experienced clinical and regulatory professionals can assist you in developing a comprehensive clinical development strategy for your device at every stage of production.
  • Clinical study management support through LICENSALE.COM®, which acts as the central file location for trial master files.
  • Clinical research administration, including screening of investigators, qualification of clinical sites, budgeting and contract negotiation, completion of regulatory documents, IRB (Institutional Review Board) liaison, CTA and IDE applications and supplements, clinical data quality management, and compliance monitoring.

CERTIFICATION

Certificate of Free Sale (CFS) / Certificate of Foreign Government (CFG) obtainment for all countries, including legalization.

QUALITY MANAGEMENT SYSTEMS

Quality Management Systems implementation and upgrades for European Notified Body CE Mark surveillance audits, FDA QSR audits, Brazilian ANVISA GMP compliance audits, Health Canada CMDCAS, Argentina’s ANMAT GMP audits, and more. The experience and support of our experts, with a track record of thousands of successful audits globally, can dramatically reduce the burden on your Quality Assurance staff.

  • Third-party quality system audits
  • Audit preparation
  • ISO 13485 and/or 9001 Quality Management System preparation and implementation
  • Quality System Regulation (QSR) preparation
  • Clean Room certification with Standard Operating Procedures (SOPs)
latest news
  • Mar 21 2017
    MEET MDSAP TRANSITION DEADLINE TO CONTINUE TRADING ON CANADIAN MARKET

    In vitro diagnostic (IVD) and medical device manufacturers must transition to the Medical Device Single Audit Program (MDSAP) before January 1, 2019 in order to continue trading on the Canadian market. ...

    Read More
  • Mar 17 2017
    HAVE YOUR SAY ON CLASS II DEVICE PREMARKET NOTIFICATION EXEMPTION PROPOSAL

    The US Food and Drug Administration (FDA) is requesting public comments on a list of 1,003 class II devices that it is proposing to exempt or partially exempt from the premarket notification [510(k)] requirements. ...

    Read More
  • Mar 16 2017
    EMPOWERING REGULATORY AFFAIRS CONSULTANTS IN 100+ MARKETS

    Independent regulatory consultants are invited to register for exclusive offers that would enable them to instantly boost their MedTech product registration capabilities in 100+ markets worldwide and maximize their profit....

    Read More
  • Mar 13 2017
    REMINDER: SOUTH AFRICA’S MEDICINES CONTROL COUNCIL SETS LICENSING DEADLINES

    South Africa’s manufacturers, distributors and wholesalers of in vitro diagnostic (IVD) and medical devices must submit a license application to the Medical Control Council by the deadlines it announced in February 2017. ...

    Read More
  • Mar 7 2017
    REGULATORY UPDATE: LUMINEX

    BRAZIL: Luminex's MAGPIX® HW + SW + Reag & Calib was approved for sale with LICENSALE.COM®. ...

    Read More

VANCOUVER OFFICE

  • Phone +1 604.681.6888
  • Fax +1 604.681.6822
  • info@arazygroup.com
  •  
  • #350-1333 Johnston Street
  • Pier 32, Granville Island
  • Vancouver, British Columbia
  • Canada V6H 3R9

BACK TO TOP