Crescenzia Wellness Private Limited

Crescenzia Wellness Private Limited

City, Bengaluru, Karnataka
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Quality & Compliance

Quality Assurance

Need of ISO 13485:2016

Why need of Medical Device Quality Management System is Important?

  • To increase the possibility of producing safe and effective medical devices.
  • To comply with all regulatory requirements.
  • To meet or exceed customer expectations.
  • Improved risk management and design controls to help clients develop and improve their products.
  • Increased efficiency in supporting customers in obtaining market clearance and approval in order to accomplish ambitious sales and marketing targets.
  • To ensure compliance with industry standards and more.
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Quality Assurance

Commitment To Quality

What is ISO 10993?
The ISO 10993 series of standards address the biological evaluation, or biocompatibility, of medical devices based on material, contact type and duration. These standards cover a range of biological safety scenarios and stipulate what specific evaluations must be completed. Biocompatibility testing must be conducted in compliance with Principles of Good Laboratory Practice (GLP) and/or ISO/IEC 17025.

Why is ISO 10993 important to your business?
The primary purpose of a device biocompatibility assessment, as required by ISO 10993, is to protect patients from potential biological risks. Compliance with ISO 10993 establishes biocompatibility of a medical device confirming that it is safe for patient contact or implant and will perform its intended function without any adverse patient effects.

Why is biocompatibility testing important?

Biocompatibility testing is a critical part of the regulatory approval process for medical devices as even the best designed products can produce unintended complications if the materials used cause a biological reaction in the patient. In addition to the beneficial tissue response and the clinically relevant performance of a biomaterial, cytotoxicity, genotoxicity, mutagenicity, carcinogenicity and immunogenicity are considered to be the components which constitute “biocompatibility”.

What is ISO 10993 tests for in vitro cytotoxicity?

ISO 10993-5:2009 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion. The cytotoxicity test is one of the biological evaluation and screening tests that use tissue cells in vitro to observe the cell growth, reproduction and morphological effects by medical devices.

What is ISO 10993-10 2010 tests for irritation and skin sensitization?

ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.

What is ISO 10993-23 tests for irritation?

ISO 10993-23:2021 is a new standard that specifies procedures for assessing the irritation potential of medical devices, materials or their extracts. The evaluation of biological safety is one important piece of the puzzle to demonstrate the safety of a medical device.
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Commitment To Quality

Reach Us
Sridhar SR (Director)
Crescenzia Wellness Private Limited
B-103, Block-III, Ground Floor, KSSIDC Complex, Behind Traffic Police Station, Electronic City Phase 1, Bengaluru - 560100, Karnataka, India
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