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MDD to MDR

Posted by Aniket Chaudhari on April 19, 2024 at 4:59am 0 Comments

IZiel alongwith their partners (Obelis) provide a “One-Stop Shop” to assist medical devicemanufacturers for MDD-MDR transition. IZiel ensures to focus on regulating medical devices throughout its lifecycle rather than focussing on any one stage, which is the need of MDR. The MDR seeks to address these concerns so that the end users do not face major safety or quality issues.

Read more@ https://iziel.com/ce-approval-mdr/

Configuration Management for Medical Device

Posted by Aniket Chaudhari on April 19, 2024 at 4:58am 0 Comments

IZiel works in collaboration with your team to develop the complete Design History File (DHF) including requirements management, risk management, process validations and software validations using robust design controls process and quality system procedures. Thereafter, IZiel team works with their regulatory team in USA to complete the submissions (510k or PMA) and resolve queries, if any, from USFDA.

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Form 483 Compliance

Posted by Aniket Chaudhari on April 19, 2024 at 4:57am 0 Comments

IZiel provides expert solutions to remediate FDA 483 observations and warning letters. IZiel team works with medical device companies across the globe to achieve regulatory and standard compliances. We take great pride in implementing best practices in Design-Development Process and Quality Management Systems ensuring effective and timely deliveries.

Read more@ https://iziel.com/remediation/

And high quality of steel tube usually does chemical analysis and mechanical test for each lot of raw material,and each single pipe without eddy current detection and hydraulic test is not allowed to deliver. If the chart before buying any or doing any projects with pipe. Quality control of raw materials is identity and marking of material, conformity of material test reports, dimensions quality of surface and steel pipe product inspection and test.

Steel pipe is everywhere. Pipe can be fabricated for many purposes. Look at the used for billboard structures when traveling down most any highway.

Titanium Tube

Look around you. Steel pipe is everywhere! Anywhere you turn or look, you will see some sort of structure or means of conduit, that steel tube is being used for. And that's not to mention the pipe that is "out of sight, out of mind" that is serving its purpose under the ground.

The second and most "Electric Resistance Welded" Pipe, starts out as a reel or cut-to-width coil of steel, known as "Skelp". The Skelp is rollers that make it round and then as the edges come together, an electric welder makes the longitudinal seam down the length ERW pipe, the edges are heated up to create the pipe. Larger O.D. steel tube can be made by rolling and welding pieces of steel plate into cylinders or "Cans" and then welding them together end to end to make the pipe.

Titanium Sheet

In addition to all of the structural applications, pipe is used by the mile for potable water lines and drainage purposes. But the main use of a new prime pipe product is "Line Pipe" that is used in the oil and gas industry for conveyance of product from the rig to the refinery. No used pipe that was taken up from the ground after being decommissioned, new surplus pipe that world.

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