This standard identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It lists symbols that satisfy the requirements of the standard and is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements. These symbols may be used on the medical device itself, on its packaging or in the associated documentation.
The standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. Using ISO 9001:2008 helps ensure that customers get consistent,
good quality products and services, which in turn brings many business benefits. It can be used by any organization, large or small, regardless of its field of activity. In fact ISO 9001:2008 is implemented by over one million companies and organizations in over 170 countries.
Sterling Medical Registration provides quality system implementation for any type of organization.
Medical Device manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. Medical Device manufacturer who intends to markets its medical device at EU / EFTA countries must implement quality management system with accordance to ISO 13485:2016. Provided here, are part of the essential international standards that a medical device manufacturer has to comply with, depends on the type of organization, the activities of the organization and the type of medical device.
ISO 13485:2016 International Standard specifies the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
Medical Device manufacturers must ensure compliance with the quality system regulations where they market their devices.
At the USA manufacturers must ensure compliance with the FDA Quality System Regulation (QSR) 21 CFR 820, which requires that each manufacturer shall establish and maintain a Quality System that is appropriate for the specific medical device designed or manufactured.
At Canada manufacturers must ensure compliance with the Canadian Medical Devices Single Audit Program (MDSAP). ISO 13485:2016 has to be certified by Canadian Medical Devices Conformity Assessment System. This certification is required prior to market your medcial device at Canada.
Sterling Medical Registration implements Quality System for medical devices companies.
This standard specifies a method of fatigue testing of single post endosseous dental implants of the transmucosal type and their premanufactured prosthetic components. It is most useful for comparing endosseous dental implants of different designs or sizes.
Sterling Medical Registration have great experience with Dental Implant System included with all related devices and accessories, thus, we can guide you and assist you with the type of product test that should be applied to your system. With accordance to your medical device we will assist to determine which of the mechanical test are applied to your device.
Sterling medical Registration
This standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.
Sterling Medical Registration implements risk management procedures, guidance and training for medical devices companies.
There are many International Standards related to product and process validation, product sterilization and validation. We will assist you to determine what are the applicable processes, validation and sterilization method are applicable to your medical device. We will also connect you and coordinate for you the applicable testing to be carry out by a certified GLP Laboratories.
Some of the standards related product and/or process validation are provided here:
ISO 11135 Sterilization of health care products - Ethylene oxide
ISO 17665 Sterilization of health care products - Moist heat
ISO 11137 Sterilization of health care products – Radiation
ISO 11737 Sterilization of medical devices - Microbiological methods
ISO 11607 Packaging for terminally sterilized medical devices
Our range of services:
· Implementation of a full quality management system with accordance to all applicable standards and regulations.
· Quality System maintenance and Document Control.
· Quality Internal Audits - An organization must perform internal audits to check how its quality management system is working.
· Quality External Audits - An organization must perform external audits to its suppliers and subcontractores to ensure compliance with the quality management system and device specifications.
· Quality Trainings - We provide training to employees and management team on the following topics: Quality System, Quality Control, Risk Management, Design Control & Development, Clean Room, Corrective and Preventive Actions, MRB and other training needs.
· Establishment and maintenance of Design Control File, Risk Management Risk Analysis File and other services by request.
· Customer Complaint handling and Medical Device Reporting.
This standards specifies the general principles governing the biological evaluation of medical devices within a risk management process; the general categorization of devices based on the nature and duration of their contact with the body; the evaluation of existing relevant data from all sources; the identification
of gaps in the available data set on the basis of a risk analysis; the identification of additional data sets necessary to analyze the biological safety of the medical device; the assessment of the biological safety of the medical device.
Cytotoxicity (Tissue Culture)
Cell culture assays are used to assess the biocompatibility of a material or extract through the use of isolated cells in vitro. These techniques are useful in evaluating the toxicity or irritancy potential of materials and chemicals.
Sensitization Assays
Sensitization studies help to determine whether a material contains chemicals that cause adverse local or systemic effects after repeated or prolonged exposure. These allergic or hypersensitivity reactions involve immunologic mechanisms.
Irritation Tests
These tests estimate the local irritation potential of devices, materials or extracts, using sites such as skin or mucous membranes, usually in an animal model.
Intracutaneous Test
Intracutaneous Test reliable to detect the potential for local irritation due to chemicals that may be extracted from a biomaterial.
Acute Systemic Toxicity
Acute Systemic Toxicity tests detects leachables that produce systemic (as opposed to local) toxic effects.
Subchronic Toxicity
These tests are used to determine potentially harmful effects from longer-term or multiple exposures to test materials and/or extracts during a period of up to 10% of the total lifespan of the test animal.
Genotoxicity
Genotoxicity evaluations use a set of in vitro and in vivo tests to detect mutagens, substances that can directly or indirectly induce genetic damage directly through a variety of mechanisms.
Implantation Tests
Implant studies are used to determine the biocompatibility of medical devices or biomaterials that directly contact living tissue other than skin (e.g. sutures, surgical ligating clips, implantable devices, etc.). These tests can evaluate devices, which, in clinical use, are intended to be implanted for either short-term or long-term periods.
Histopathology
After the implant site is recovered and examined microscopically for tissue reaction. The histopathologist can detect and describe many types of tissue and immune system reactions.
Hemocompatibility
Materials used in blood contacting devices (e.g. intravenous catheters, hemodialysis sets, blood transfusion sets, vascular prostheses) must be assessed for blood compatibility to establish their safety.
Carcinogenesis Bioassay
These assays are used to determine the tumorigenic potential of test materials and/or extracts from either a single or multiple exposures, over a period consisting of the total lifespan of the test system.
Reproductive And Developmental Toxicity
These studies evaluate the potential effects of test materials and/or extracts on fertility, reproductive function, and prenatal and early postnatal development. They are often required for devices with permanent contact with internal tissues.
Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device.
Clinical evaluation is an ongoing process conducted throughout the life cycle of a medical device. It is first performed during the conformity assessment process leading to the marketing of a medical device and then repeated periodically as new clinical safety and performance information about the device is obtained during its use.
Sterling Medical Registration provides with clinical evaluation and studies services with accordance to International Standards, the European regulations, USA FDA regulation and any applicable market regulation.
Sterling Medical Registration will assist you determine what type of biocompatibility testing are required for your medical device. We will also connect you and coordinate for you the biocompatibility testing to be carry out by a certified GLP Laboratories.
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