Press | WOW Success

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WOW fusion gains ISO certification

This article was originally published on Wigmore Medical and does not belong to WOW facial®. Read the original article on Wigmore Medical.

The WOW fusion® device is an innovative needling device that allows the practitioner to create bespoke skincare cocktails tailored to the clients’ individual needs. The needle head contains 20 surgical steel needles which are electroplated with nickel and 24k gold. The needles are ultrafine in diameter, at 0.13mm. These are tapered to aid the flow of product into the skin to the dermal/epidermal junction. This treatment is ideal for improvements in skin concerns such as rosacea, fine lines and wrinkles, oily skin, excessive facial sweating, production and excess sebum production.

As part of an 18-month project, WOW facial ltd. embarked and put into operation the complete quality management system to apply for ISO certification for medical device manufacturing. Following an extensive audit from NQA, WOW achieved EN ISO 13485:2016 certification in October 2021. This will assist WOW’s FDA application for WOW fusion® as a Class 2 medical device, and their eventual CE marking in accordance with medical device regulations (MDR).

Understanding Quality in Aesthetics

A lack of regulation in the UK has allowed an influx of unregulated products onto the market with many companies taking advantage of the situation without any consideration for patient safety and the only way to prevent this from happening is if practitioners refuse to use unregulated products so having a basic understanding what standards are required to make medical devices is essential. ISO certificates are issued by the International Organisation for Standardisation (ISO).
ISO 13485:2016 is a certification for the medical device industry to ensure that medical devices are manufactured in line with the stringent regulations. It is an internationally recognised system and acknowledges the requirements for a comprehensive quality system suitable to design and develop medical devices.
There are five key elements of the ISO 13485:2016 standard:
1—A quality management system
2—Management responsibility
3—Resource management
4—Product realisation
5—Measurement, analysis, and improvement
"I am very proud of what the team at WOW have achieved…Manufacturing the device to this high standard puts patient safety at the core of what we do" Claire Williams, CEO and founder of WOW facial®

WOW facial ltd. has successfully shifted to a quality-driven culture that the whole team have embraced, ensuring that patients’ safety and quality are at the core of its business.

The CEO of WOW facial ltd., Claire Williams, says, “I am very proud of what the team at WOW have achieved over the last 12 months. Introducing this level of regulation and quality into the way we manufacture the WOW fusion® device has taken a lot of hard work, dedication, and intellect. Manufacturing the device to this high standard puts patient safety at the core of what we do—and I will continue to regulate and ensure safety in the aesthetic medical arena. The ISO 13485:2016 proves the strength and determination of our organisation to improve quality and safety. It demonstrates our commitment to our customers to enable them to be confident they are always delivering a high-quality treatment when using WOW facial® products. The certification means that we always manufacture our WOW fusion® device in line with the regulations of how class II medical devices should be manufactured."

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The latest innovation in skin rejuvenation

Advanced WOW fusion® training offers medical practitioners the opportunity to learn about the benefits of using Botulinum Toxin A intradermally as part of the WOW fusion® protocols. Learn how to hyper-personalise your treatments using the various WOW fusion® solutions inside the device to offer a truly tailored signature service.

The WOW fusion® system and serums can improve:

✓ Fine lines and wrinkles
✓ Excessive facial sweating
✓ Hyperpigmentation
✓ Dehydrated skin
✓ Open pores
✓ Dull Skin
✓ Rosacea
✓ Redness
✓ Oily skin
✓ Acne

The WOW fusion is available now from Wigmore Medical. For more information or to purchase, call 020 7491 0150 or email orders@wigmoremedical.com

Read the original article on Wigmore Medical