Quality and Compliance

Committed to Quality Without Compromise

Our Quality Policy:

Exsurco Medical is committed to a policy of “Quality Without Compromise.” We are committed to exceeding our customers’ expectations by developing and delivering safe and effective medical devices. Through vigilant implementation and maintenance of our quality management system, we are committed to the highest quality standards for the patients we serve. We will achieve this by:

  • Complying with applicable quality, safety, and regulatory requirements
  • Monitoring our customers’ total experience
  • Continuously developing and improving medical devices that redefine excision science
  • Conducting ourselves with integrity and striving for excellence in all we do

Service

Exsurco Medical is here to serve you and assist you with any questions that may arise while using our products.  Exsurco guarantees you will be satisfied with our product.  If for some reason you are not satisfied with our product (both the single sterile and reusable) please refer to the below information for help in requesting service for your product:

  • Should one of our products require service please contact customer service at support@exsurco.com or 1-800-243-6049 x4.  Our customer service team will issue you a return authorization number in order to process your return.
  • We cannot accept products back to our facility without a return authorization for business tracking purposes.
  • All of our reusable devices that require sterilization for use must be clean and sterilized prior to being returned.  A proof of sterilization is required on all returned devices.
  • All devices must be shipped in a safe and protected manner to prevent damage.  If there is concern regarding the return shipping carton please contact our customer service team.  You may be required to purchase a return shipping transportation case for our reusable products.

Customer Service Policy

Warranty

  • Exsurco reusable devices (the Amalgatome SD,  Amalgatome® MD and Amalgatome® SK) carry a one year warranty from date of purchase.  Should your device require any type of repair or service during this period it is covered under the warranty.  Please contact our customer service to set up a return through our return authorization process.  Per the operator's manual it is noted that in order for repair to be covered under warranty, the device must NOT have been altered in any manner or repaired by anyone other than our Exsurco Technical Service Department.  Exsurco reserves the right to bill for repairs under the warranty period if it is determined that the customer has abused the device.
  • The one year warranty covers all parts and repair service during this period (both for complaints and non-complaints) for our reusable devices.
  • Our sterile disposable items are one-time use and do not carry a warranty.  If for some reason a customer is not satisfied with the product, please call or email customer service above to request a credit or replacement item.
  • If during the warranty period your device must be returned, Exsurco may provide a loaner device to use while the return is being evaluated and/or repaired.  This is all part of the Exsurco Return Policy and will be explained by our customer service department when issuing the Return Authorization.

Repair

  • Exsurco Medical has a fully staffed, expert technical service and repair department on site.  We do NOT send any product out to a third party for repair.  Our skilled repair technicians will coordinate and perform all the device repairs.
  • Should your device be past the Warranty period and require a repair, please contact our customer service department: support@exsurco.com or 1-800-243-6049 x4 and request a Return Authorization.
  • Your return will be evaluated and an estimated repair statement be sent to the customer for authorization of the repair prior to the work being performed.
  • Loaner units are also available during the post warranty repair period and should be requested at time of the return.
  • Our service department will perform a complete Service Repair Order and indicate the repair work performed on the device upon return to customer.
  • Please note that an extended warranty for our devices are available for purchase.  Please contact your Exsurco Sales Rep at: sales@exsurco.com or 1-800-243-6049 x1.

Quality Questions

  • Exsurco stands behind the quality of our devices.  Should a customer have a complaint or not be completely satisfied with our product, please call Customer Service to register a complaint, support@exsurco.com or 1-800-243-6049 x5.
  • In addition, a complaint form can be emailed to the customer to better facilitate handling of any issue or concern.  To help investigate the event further, we will require the following information at a minimum:
    • Name and address of complainant, including phone number and email
    • Account number of the complainant
    • The part/product that the complaint is being filed against
    • The serial or lot number in question
    • A brief description of the event and any pictures, if available
    • For the reusable devices, return the product and loaner, if needed
  • Upon receiving the complaint, you may receive a follow up phone call requesting more information. Once the product is returned, a preliminary evaluation is generally conducted and the product is repaired (if required), restored to conformance, and shipped back. A closure letter will be provided advising the customer of the outcome of the investigation regarding the reported event.
  • The Service Repair Order of the repaired device will also be sent detailing the repairs performed by our technical service department.

    Exsurco Quality Manual

  • Corporate Compliance and Code of Ethics

    Exsurco Medical, Inc. is committed to upholding the highest standards of ethics, integrity and accountability in pursuit of our mission and purpose. To achieve this, we must strive for excellence in all of our behaviors and everything we do. Our commitment to these standards are the core values of our company.  We understand that the laws and regulations in the health care industry are complex and Exsurco’s Code of Ethical and Business Conduct has been developed to assist you in better understanding your responsibility and how Exsurco Medical expects each of us to conduct business. It is expected that you will use this document and the philosophies outlined as you conduct your daily tasks and work towards making Exsurco Medical, Inc. a best-in-class medical device company.

  • Purpose of our Corporate Compliance Program:  Exsurco is dedicated to be compliant to our Corporate Compliance Program while driving to meet our Vision and Objectives. Exsurco will conduct business ethically, with integrity and in compliance with all applicable federal, state, and local laws and regulations. In particular, Exsurco is particularly mindful of its obligations with respect to anti-fraud, false claims, and anti-kickback statutes.We can achieve adherence by creating a working environment where: there are ethical and proper ways to do business, commitment to our customers, encourage reporting of violations, provide processes with constant monitoring and auditing, and provide processes which help prevent, detect or deter non-compliant behavior.
  • It is the responsibility of leadership and employees of Exsurco Medical to follow the Code of Ethical and Business Conduct
  • Reporting and Seeking Compliance Assistance:  Exsurco expects all employees, vendors and other business partners to report any non-compliance that is observed. Reporting can be done anonymously as there is a strict policy against any retaliation against anyone or business for good faith reporting.   Compliance Hotline/ Email:  compliance@exsurco.com

Need Assistance?

Our Cleanroom

We are proud of our dedicated Class 7 Cleanroom (pictured above) which ensures your product is manufactured in a clean, controlled environment. Ensuring your product is handled by our dedicated cleanroom staff allows us to produce and deliver exceptional product built to high quality standards, built on exceeding your expectations.

Exsurco Medical is an ISO 13485 and FDA Registered Medical Device Company.  Our products are available for use both in tissue banks for CADEVERIC USE ONLY, and for Healthcare Professionals for patient use in surgical environment.  Please follow the device labeling for proper use.

View FDA Registration (PDF)

View ISO 13485 Certificate (PDF)