The CardioMed Quality Management System is registered to ISO 13485:2003 as required by the Canadian Medical Devices Conformity Assessment System (CMDCAS) and has been approved in conformity with the requirements of Annex V, section 3.2 - Production quality assurance of Council Directive 93/42/EEC concerning medical devices. In addition, CardioMed is compliant with FDA 21 CFR Part 820 Quality System Regulation. The Quality Management System provides a framework for excellence in product design and development, the quality of our manufactured goods, delivery times, and the elimination of non-value added costs.
CardioMed produces safe and reliable medical products for the health care industry with consideration given to utmost quality. It is our policy to continuously monitor and indentify our customers' quality needs and promptly meed their expectations today, while concurrently anticipating the requirements of tomorrow.
Quality system management and quality control are vital factors in production and assembly. Cardiomed adheres to the principles of ISO 13485:2003. CardioMed abides by the laws and directives that govern the medical devices industry:
CardioMed is committed to highly qualified and trained personnel, and quality is built into every Medical and Health Care product made at CardioMed through our commitment to the finest quality of suppliers.
Please feel free to download the posted copies of our various quality certifications here. It is suggested that you right click the link and select "Save Target As..." to save the PDF file to your computer.
CardioMed ISO 13485:2003 Certificate of RegistrationOur ISO 13485:2003 certificate as issued by our Standards Council of Canada Accredited Registrar (BSI).Best printed on Letter sized paper in Landscape orientation.Download Certificate
CardioMed Medical Device Establishment License Our Medical Device Establishment License as issued by Health Canada.Best printed on Letter sized paper in Portrait orientation.Download Certificate
CardioMed EC Certificate (CE Mark)Our EC Certificate (Annex V, Section 3.2 of Council Directive 93/42/EEC Concerning Medical Devices) as issued by our Notified Body (BSI), Best printed on A4 sized paper in Portrait orientation. Download Certificate
Product Warranty and Return Policy
Non-sterile Medical Products
CardioMed Supplies Inc. warrants that non-sterile medical products that are unopened will perform as designed, free from defects in materials and workmanship, for one year from the date of sale, or five years from the date of manufacture, whichever is longer. Products that have been opened for clinical use will be warranted for the duration of their recommended period of use (see the directions for use for the recommended product application).
Exceptions: Incontinence Enema Catheters are warranted for 100 days from the date of sale.
Sterile Medical Products
CardioMed Supplies Inc. warrants that sterile medical products that are unopened will perform as designed, free from defects in materials and workmanship, up to and including their expiration date.
Products that have been opened for clinical use will be warranted for the duration of their recommended period of use (see the directions for use for the recommended product application), even if that period of use extends beyond the expiration date. Example: A temporary dialysis catheter with a recommended period of use of 30 days is inserted in a patient 10 days prior to product expiration. This catheter will be warranted for the full 30 days of its intended use.
Distributed Medical Products (not Electronic Products; see relevant section)
Products distributed by CardioMed Supplies Inc. are warranted by the manufacturer for defects in materials and workmanship, not by CardioMed. As the manufacturer’s agent, all product concerns should be reported to CardioMed. CardioMed will assist with product investigation, replacement and/or retraining as may be required.
Electronic products distributed by CardioMed Supplies Inc. are warranted by the manufacturer for defects in materials and workmanship, not by CardioMed. The product warranty offered by the manufacturer is the same warranty offered by CardioMed. Where no warranty is expressed or provided by the manufacturer, CardioMed shall offer a 90 day limited warranty. CardioMed reserves the right to inspect product for mishandling before issuing a replacement product, or authorizing the repair of the item. The decision to replace or repair the product is at the sole discretion of CardioMed Supplies Inc. and/or the manufacturer.
All returns to CardioMed Supplies must be approved in advance by either the Quality Assurance Department or the Customer Service Department. Depending on the nature of the return, either a Customer Complaint number (CCN) or a Return Goods Authorization (RGA) number will be issued. The appropriate CCN or RGA number must be clearly identified on the outside packaging of the product in order to guarantee that the product return is processed in a
Please review the following sections regarding the conditions of specific returns.
Errors due to shipping irregularities must be reported to CardioMed’s Customer Service Department within 10 business days from the date of shipping, or 5 business days from the date of receipt, whichever is longer. This includes, but is not limited to; short shipments, over shipments, and damaged shipments.
Note: for shipments made collect on the customers courier account, it is the responsibility of the customer to contact the courier to make a claim for any and all damages that may have occurred during shipment.
Ordering errors and inventory adjustments
Return requests for items ordered in error or for the incorrect quantity are to be made through CardioMed’s Customer Service Department. The allowable period for returns is based upon the ORIGINAL invoice date of the order. Return requests for products with an invoice date less than 30 days prior to the date of request can be processed immediately. Return requests for products with an invoice date more than 30 days but less than 6 months prior to the date of request, will require the approval of the sales manager. Returns for products with an invoice date more than 6 months prior to the date of request cannot be accepted. Please note:
CardioMed will not accept returns strictly for the purpose of inventory reduction. CardioMed will not accept returns for custom built products or special order items.
Should a customer feel that CardioMed Supplies has shipped a product with an insufficient period of time before expiration, this will be handled under the same process as an incorrect shipment. The only additional step will be to determine the validity of the claim, which may involve an investigation by the Quality Assurance Department, and a clarification as to the usage by the sales representative for the account.
Defective Products, Corrective Actions and Recalls
Return requests relating to defective products, products not operating as designed or intended, or under product recall still require a RGA number for tracking purposes.
If you have a product that you believe is not performing as required, you will be directed to the Quality Assurance Department for investigation prior to a return authorization being issued or a corrective action being taken. The QA department will notify Customer Service as to whether the RGA is to be issued following the investigation. Products are NOT to be returned to CardioMed unless the QA department or CS department approve the return.
If you have a product that is under recall, you must first notify CardioMed’s Quality Assurance Department in order to verify that the product code, lot number, and other relevant product details are applicable to the recall before requesting a RGA number from the Customer Service Department. The QA department will notify the CS department that the RGA should be issued.
Restocking charges are intended to recover the costs of receipt, inspection, repackaging and labelling, re-shelving in the warehouse, and the administration costs of processing the RGA and the Credit Memo. As such, all returns may be subject to a restocking charge.
CardioMed’s standard restocking charge is 25%, however several factors may affect this charge. These factors include, but are not limited to: elapsed time from date of purchase; amount of handling required; repackaging and labelling; contract obligations. Therefore the restocking charge may be increased to a maximum of 30%.
Restocking charges will not be applied under the following conditions:
- where the return is due to defective product, corrective action or product recall
- where the return is due to an over-shipment or incorrect shipment
NOTE: the exception to this would be where the client has obviously opened or mishandled the product
Return Freight Charges
Return freight charges are the responsibility of the customer, with the following exceptions:
- where CardioMed has shipped the wrong product, CardioMed will pay the return freight charges for the wrong product and will pay the freight to re-ship the correct product
- where CardioMed has over-shipped a product, CardioMed will pay the return freight charges for the overage
- where the return is for a product under recall or corrective action
Defective products may be returned at CardioMed’s expense only if the Quality Assurance department has approved this action after identifying the nature of the defect, and a RGA number has been issued by the Customer Service Department.
This policy is subject to change. Please contact the Customer Service Department, or visit our website at http://www.cardiomed.com to obtain the most current policy. This is CardioMed Supplies’ standard policy; your facility may have a contract with slightly different conditions. Please contact your contract administrator for details.