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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/

Indoor Pace Recorded Incorrectly by Apple Watch? Here’s the Fix

Are you a workout freak? Exercising is a vital part of one’s life as it keeps you fit and healthy. Be it taking a jog in the morning, or hitting the gym in the evening; it is important to keep track of your habits.

If you’re an Apple Watch user, it can add up to the advantage as it enables you to track your workout routine. However, sometimes inconsistency may arise while recording. For instance, the Watch might show a slower pace while running on a treadmill inside than going for a jog in a park even if the pace was the same.

In case you find something off with your Apple Watch while recording your workout sessions, below is the guide on a possible fix.

How to Check the Location and Motion Settings of Your Apple Watch?

The steps to check the location and motion settings of your Apple Watch:

Go to the ‘Settings’ app on your iPhone.
Locate the ‘Privacy’ tab and click on the same.
Select ‘Location Services’ in the next window.
A location services menu will open. Select the ‘System Services’ option.
Turn the slider on for the ‘Motion Calibration & Distance’ option, if it’s disabled.
How to Calibrate Your Apple Watch?

The steps to calibrate your Apple Watch are:

Wear your Apple Watch and head out in an open area.
Launch the ‘Workout’ app on your Apple Watch.
Select any of the two options: Outdoor Walk or Outdoor Run, before beginning your workout.
Walk or take a jog for about 20 minutes at a normal pace.
According to Apple’s guidance, Apple Watch measures your pace, and the GPS service will take a note of the distance traveled.

How to Reset Your Calibration Data?

As mentioned above, if your Apple Watch does not measure the actual scale of your workouts, you can reset the data and start fresh. The steps to reset your calibration data are:

Go to the ‘Watch’ app on your iPhone.
Tap on the ‘My Watch’ tab in the bottom-left corner of the screen.
Select the ‘Privacy’ option in the next menu window.
Click on the ‘Reset Fitness Calibration Data’ option.
Resetting the calibration data is likely to fix the issue arising with your Apple Watch. However, if it doesn’t make a difference, you can always opt to take professional help.

SOURCE:- Indoor Pace Recorded Incorrectly by Apple Watch? Here’s the Fix

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