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Electrode Pads

Electrode Pads
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Electrode Pads

Product catalog summary

Overview of Medical Device Single Audit Program (MDSAP)

The Medical Device Single Audit Program (MDSAP) is an international initiative designed to allow a single regulatory audit of a medical device manufacturer's quality management system to satisfy the requirements of multiple regulatory jurisdictions.

Main Sections

1. Program Specifications

MDSAP specifies a standardized audit model that covers the requirements of participating regulatory authorities, including but not limited to the US FDA, Health Canada, Brazil's ANVISA, Japan's PMDA, and Australia's TGA. The audit focuses on compliance with ISO 13485 and additional country-specific regulatory requirements.

2. Audit Procedures

The audit process under MDSAP includes planning, execution, reporting, and follow-up. Audits are conducted by authorized auditing organizations trained and recognized under the MDSAP framework. The audit covers quality management system processes, product realization, and regulatory compliance.

3. Regulatory Requirements and Standards

MDSAP audits assess compliance with ISO 13485:2016 and applicable regulatory requirements from participating countries. This includes documentation control, risk management, product traceability, complaint handling, and post-market surveillance.

4. Recommendations and Best Practices

Manufacturers are encouraged to maintain robust quality management systems aligned with ISO 13485 and to prepare for MDSAP audits by understanding the specific regulatory expectations of each participating authority. Continuous improvement and thorough documentation are critical for successful audits.

Key Points

  • MDSAP enables a single audit to satisfy multiple regulatory requirements, reducing audit burden.
  • Audits are conducted by authorized organizations following a harmonized audit model.
  • Compliance with ISO 13485 and country-specific regulations is mandatory.
  • Manufacturers should focus on comprehensive quality management and regulatory compliance.
See more

Catalog excerpts

Electrode Pads-1

healthcare &Medical ► KM-801 Palm Pad With Snap Material: Non-woven; Conductive gel; Carbon film. Size: 4.5*7.5cm; Snap: 3.5mm. ► KM-802 Small Pad With Snap Material: Non-woven; Conductive gel; Carbon film. Size: 3*4.5cm; Snap: 3.5mm. Packing: 1 pair/ PE bag; N.W: 0.65kg/ lOOpairs. ► KM-805 Square Pad With Pigtail Material: Non-woven; Conductive gel; Carbon film. Size: 5*5cm; Pigtail pin: 2.0mm. ► KM-806 Rectangle Pad With Snap Material: Non-woven; Conductive gel; Carbon film. Size: 4*8cm; Snap: 3.5mm. ► KM-803 PET Pad With Snap Material: PET; Conductive gel; Carbon film. Size: 6.7*4.2cm; Snap: 3.5mm. ► KM-807 Big Pad With Snap Material: Non-woven; Conductive gel; Carbon film. Size: 6*9cm; Snap: 3.5mm. ► KM-804 Square Pad With Snap Material: Non-woven; Conductive gel; Carbon film. Size: 5*5cm; Snap: 3.5mm. ► KM-808 Large Pad With Snap Material: Non-woven; Conductive gel; Carbon film. Size: 5*10cm; Snap: 3.5mm.

 Open the catalog to page 1
Electrode Pads-2

konmed+* healthcare &Medical ► KM-810 Large Pad Pigtail Material: Non-woven; Conductive gel; Carbon film. Size: 5*1 Ocm; Pigtail pin: 2.0mm. ► KM-817 Eye Pad With Pigtail Material: Non-woven; Conductive gel; Carbon film. Size: 21*1 Ocm; Pigtail pin: 2.0mm. ► KM-812 Big Pad With Pigtail Material: Non-woven; Conductive gel; Caibon film. Size: 6*9cm; Pigtail pin: 2.0mm. ► KM-813 Silicone Pad With Insert Hole Material: Silicone; Conductive gel; Carbon film. Size: 4*6cm; The insert hole: 2.0mm. ► KM-830 Round Pad With Pigtail Material: Non-woven; Conductive gel; Carbon film. Size: 05cm; Pigtail pin:...

 Open the catalog to page 2
Electrode Pads-3

konmed+* healthcare &Medical ► KM-824A Swallowing Pad With Pigtail Material: Non-woven; Conductive gel; Carbon film. Size: 8.5*5cm; Pigtail pin: 2.0mm. ► KM-863 Gourd Electrode Pad With Pigtail Material: Non-woven; Conductive gel; Carbon film. Size: 6*9cm; Pigtail pin: 2.0mm. ► KM-824B Swallowing Pad With Snap Material: Non-woven; Conductive gel; Carbon film. Size: 8.5*5cm; Snap: 2.2mm. ► KM-828 Waist Pad With Pigtail Material: Non-woven; Conductive gel; Carbon film. Size: 11*15cm; Pigtail pin: 2.0mm. ► KM-850 Grey Silicone Pad With Insert Hole Material: Silicone; Carbon film. Size: 09.5cm 06.5cm;...

 Open the catalog to page 3

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.