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Provide Medical Device Consulting and Regulatory Requirements Compliance Services

for ISO 13485, CE Mark and FDA Compliance for Medical Devices.

A GMP specialist will full medical device manufacturing and quality management expertise.  

Seeking new medical products and medical product certification Home Page > Standards Certification

Certification

From BSI Singapore, TUV-SUD -PSB and SGS:

ISO 13485:2016 Certification

The certification of a quality management system, specifically for medical devices, to ISO 13485 proves advantageous, and in many cases essential, for medical companies which export their products to the global market.

ISO 13485: 2016 has been harmonised against the three Directives (Medical Devices, In-vitro Diagnostic Devices and Active Implantable Devices) so certification to this standard by an accredited certification body such as BSI automatically demonstrates compliance with specific clauses in the regulations.

Benefits of ISO 13485:

  • Formal certification, specifically for medical devices to ISO 13485: 2016 helps market products and services.
  • Operating costs drop as rework is reduced and efficiencies increase.

 

ISO 9001: 2015 Certification

ISO 9001:2015 specifies requirements for a quality management system for any organization that aims to enhance customer satisfaction and demonstrate its ability to consistently provide products that meet customer and regulatory requirements. ISO 9001:2015 has been organised in a user-friendly format with terms that are easily recognised by all business sectors, and companies of all sizes.

Benefits of ISO 9001:2015:

  • Operating costs drop as rework is reduced and efficiencies increase
  • Business procedures and processes become standardised
  • Increased productivity occurs as the correct information and equipment is put into place
  • Customer satisfaction grows, increasing job security for employees and profitability and market competiveness for the company.

 

Biocompatibility Evaluation of Medical Devices

Direct contact with degradable compounds released from devices such as medical implants may cause harm to the patient. The compatibility of the device material with biological tissues, cells and body fluids must be assessed according to the ISO 10993 standard.

TÜV SÜD PSB provides a comprehensive range of services such as compliant biological, chemical and physical testing in the evaluation of the biocompatibility and safety of medical devices and biomedical materials. These preclinical studies are carried out under conditions and quality management system in compliance with GLP (Good Laboratory Practices).

Our services

The biocompatibility evaluation of medical devices testing services include:

Biological test

  • Cytotoxicity
  • Sensitization
  • Skin irritation/Intracutaneous reactivity
  • Systemic toxicity
  • Genetic toxicity
  • Implantation
  • Haemocompatibility
  • Clinical biochemistry
  • Histopathology analysis
  • Other biocompatibility tests

Chemical evaluation

  • Chemical composition and characterisation
  • Impurities
  • Ethylene oxide residues
  • Degradation products from polymeric, ceramic and metallic materials
  • Leaching and migration tests
  • Leachable protein from medical gloves
  • Penetration resistance against chemicals
  • Permeation rate of chemicals and therapeutic drugs
  • Surface morphology and microstructure
  • Delamination
  • Corrosion

 

ISO9001

ISO 13485

CE Mark

FDA Requirements

EP Testing

Class VI

ISO 10993

 

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