Know Why UKCA Marking Shouldn’t Be Neglected in UAE?

Know Why UKCA Marking Shouldn’t Be Neglected in UAE?

Medical devices bearing the UKCA Mark indicate that they meet the requirements of the UK. Test results show that the device meets applicable legislation requirements. If the UKCA stamp is present on the product, the product can be freely marketed in Great Britain (England, Wales, and Scotland). 

However, UKCA Certification won’t be recognized in Northern Ireland or the EU. For devices placed on the Northern Ireland market, a CE mark or a CE UKNI mark will be required.

UKCA marks must be accompanied by a ‘declaration of conformity, i.e., the UKCA Conformity.

If the UK Approved Body has been involved in conformity assessment for certain higher-risk devices (Class Is, Im, IIa, IIb, III, self-test IVDs), there is a specific identification number as below.

  • UK government has set up a new domestic database to replace the EU’s NANDO (New Approach Notified and Designated Organisations) Information System.
  • The UKCA mark can be used by manufacturers until 30 June 2023. A UKCA Mark will be required for the sale of medical devices in Great Britain as of 1 July 2023.
  • Use of the UKCA mark is exempt from these rules. 
  • Medical devices should not be marked with the UKCA if they are:
  • Customized medical devices: It is still necessary to comply with the UK MDR 2002 requirements when using a custom-made device, and to clearly indicate its type;
  • Involved in a clinical trial: There must be a statement that the study is exclusive to clinical research;
  • In-vitro diagnostic medical devices (IVDs) are used to assess the performance of medical devices;
  • Devices that are not compliant but are used in exceptional circumstances (humanitarian reasons).

There is no need for third-party intervention in the above cases. However, there is a possibility that you may have to draw up a statement to declare compliance for custom-made devices, clinical investigations, and performance evaluation devices in some cases.

Medical Devices Must Be Marked by UKCA

The Medicines and Healthcare Products Regulatory Agency requires all medical devices placed on the market to be registered with them. It will oversee all devices on the UK market and implement vigilance, sampling, reporting, and incident management. This allows UKCA Marking in UAE manufacturers to register their products directly. For the registration of their products, manufacturers outside of the United Kingdom will need to appoint a Responsible Person.

We, at Ascent, are committed to helping our customers implement UKCA Marking. As soon as we’re designated as a UK Approved Body and develop a robust conformity assessment process for the UKCA. 

Due to the extensive experience of our two European Notified Bodies and our existing network and infrastructure in the United Kingdom, the process is facilitated in a smooth manner.

Must-to-Meet Criteria Listed Under FSC-COC Multiple Site Certification & More!

Must-to-Meet Criteria Listed Under FSC-COC Multiple Site Certification & More!

FSC-COC Multiple Site Certification is a certification that is offered by the Forest Stewardship Council. This certification program is designed to certify individuals and companies who are involved in forest management and production practices and operate multiple sites.

FSC-COS, or Forest Stewardship Council Certification of Oceans, is a non-profit organization that certifies companies in the forest sector. The organization was founded in 1993. FSC Certification allows you to earn the certificate by meeting the requirements of two (or more) sites.

This Multiple Site Certification is provided to companies that have multiple locations to manage their environmental impact. The certification ensures that you are meeting the requirements of the FSC-COC and is designed for companies that have more than one location.

FSC-COC Multiple Site Certification is also known as EIMS certification or EIMS2 certification. It is a voluntary program, which means that you do not need to be certified to submit a project for FSC Certification In UAE. However, if you want your company to be recognized by other businesses, then this is a must-have for your business.

FSC-COC certification can be obtained in the field of construction. This certification is designed for those who have already attained their General Manager certificate and want to go one step further and obtain the multiple-site certification. The FSC Forest Stewardship Council in UAE can be obtained by any person who has been working in the field of construction for at least five years.

What Does It Take to Get This Certification?

To get this certification, you need to fulfill all the requirements set out by the FSC-COC for them to consider you qualified enough to receive their approval. FSC-COC Multiple Site Certification can be obtained by individuals, companies, and organizations that are interested in improving their sustainability practices.

The first thing that you need to do is make sure that you have a certain level of experience with regard to your current position before applying for this type of certification because if not, then they will reject your application without even giving it any thought or consideration whatsoever. 

Those who seek this Forest Stewardship Council Certification must meet certain criteria including:

  1. A minimum of five years of experience working with forests;
  2. Possessing an understanding of the concepts and principles of forest stewardship;
  3. Being able to demonstrate how they implement these practices;
  4. Demonstrating how they use products or services produced from sustainably managed forests;
  5. Demonstrating how they protect water resources from contamination through the use of forest products or services.

The Bottom Line!

Concluding, the main purpose of obtaining this certification is to help you increase your value in your industry as well as to boost your career prospects. If you are looking for an opportunity to work on large projects, then this FSC Forest Stewardship Council certification will help you get there faster than others who do not have it.

Business management free of worry and risky situations.

Business management free of worry and risky situations.

With the growing economy, it has become obligatory for a business body to expand in order to earn profit. This needs more infrastructure and more economic support. Now, potential disruptions in business are way too common these days. The bigger the business, the bigger are the worries around it.

Potential disruptions can range from unexpected power cut to equipment failure or from natural disaster to industrial dysfunction. All of these can hamper a business or even may force it stop operating.

To solve all these risks and worries, business continuity management system ISO 22301 has been introduced. It is the international standard for business continuity. A business continuity plan is something that every business should have at its disposal for its continued survival. It aims to protect the business and let it prosper over a long period of time.

The key role of the ISO 22301 certification is to protect a business, financially and also its assets, by preventing potential disruptions or stoppage in operations. It enhances the credibility and trustworthiness of an organization. This creates an atmosphere of welcome for the organization around the world.

The certification gives an organization the advantage in competition by increasing business stability. It increases the performance of the products to meet the standard of the ISO 22301. The standard keeps an eye on all the processes and makes sure that none of the operations or procedures led to any kind of disruption.

Ascent EMIRATES is a leading consultancy for the business continuity management system ISO 22301 in UAE. It comes with twenty two years of experience in successfully consulting various organizations around the world. It has been involved in thousands of successful certifications throughout the world.

Ascent EMIRATES provides its consultancy on ISO 22301 accreditation in cities like Dubai, Sharjah, Abu Dhabi, Ras-al Khaimah, Ajman, Al Ain and Fujairah.

Ascent EMIRATES provides an improvement in services and relationships within and outside the organizations. It keeps transparency to the clients and also advises them about the ISO 22301 certification requirements. It works with large organizations as well as SMEs. It also steers an organization to resolve the problem regarding inadequate resources.

Ascent EMIRATES, through its effective advisory, helps organizations to cut down the ISO 22301 certification cost. It also trains personnel within the organization on the conformity needs and procedure of certification.

So, to obtain the accreditation of ISO 22301 in UAE for your business, contact Ascent EMIRATES.

 

ISO 13485: Reliable to maintain the quality of medical equipment

ISO 13485: Reliable to maintain the quality of medical equipment

With an increase in population all over the world, public health has become an issue of major concern for the government of any country. Public health now-a-days just cannot be ignored at all. For this, a huge number of medical facilities have been set up in almost every country.

Medical devices are an integral part of the medical system. It’s impossible to move ahead without them. But there is also a growing concern over the quality of the devices. To answer these, the ISO 13485 has been implemented. It is the Medical devices quality management system. The guidelines and requirements that are needed to maintain quality has been specified by the standard.

The ISO 13485 certification ensures that the products, in this case the medical devices are compliant to the quality standard set by it. It makes sure that there is constant process within the organization to improve quality of the product. It ensures that all the certified products are up to the mark.

The certification enhances the brand value and corporate image of an organization. It enhances the credibility and trustworthiness of an organization making it much more reliable among public. The certification raises the sales up with ease and also opens the door to new markets.

Ascent EMIRATES is a leading consultancy for the ISO 13485 certification in Dubai. It comes with twenty two years of experience in successfully consulting various organizations around the world. Ascent EMIRATES also has its presence in Sharjah, Abu Dhabi, Ras-al Khaimah, Ajman, Al Ain and Fujairah. It has an enormous network of experienced consultants and has been involved in thousands of successful certifications throughout the world. It helps an organization in understanding requirements of the certification.

Often, many organizations, especially the medium and large sized ones, avoid the certification procedure due to the complicated technical requirements. But, the positives of the certification hugely undermine the negatives. This is where Ascent EMIRATES excels.

Ascent EMIRATES provides an improvement in services and relationships within and outside the organizations. It keeps transparency to the clients and also advises them on the ways to improve. It works with large organizations as well as SMEs. It also trains personnel within the organization on the conformity needs and procedure of certification. It also steers an organization to resolve the problem regarding inadequate resources.

Ascent EMIRATES, through its effective advisory, helps organizations to cut down the ISO 13485 certification cost. It also trains personnel within the organization on the conformity needs and procedure of certification.

So, to obtain, ISO 13485 certification cost in UAE for your product, contact Ascent EMIRATES.

GOST R – Unlock the door to business in Russia

GOST R – Unlock the door to business in Russia

With the growing population, the economy is also on the growth. It has become obligatory for a business body to expand in order to earn profit. For this, businesses are venturing into new countries. This opens the door of new market and profitability.

Now, it is well known that, to for a certain product to be sold in a particular country, it is essential to have the product marking of that country. For the markets of Russia, the product marking required is GOST R marking. The Russian standards mostly vary from that of the European ones. The certification has attracted a huge number of opportunities opening the door to Russian market.

GOST R certificate not only allows trading in the Russian market, but also it comes with some other benefits. It enhances the brand value and corporate image of an organization. It brings customer satisfaction. It increases the credibility and trustworthiness of the organization. Also, it reduces the risk of fraudulent incidents. This enhances consumer safety. The procedure is a time and money saving one.

There are products for which the GOST R certification is compulsory. These include Food Products, Machinery, Medicinal Devices, Electronic and Electrical Products, Cosmetics, Household chemicals, Consumer packaging materials. Products other than these can also acquire the certificate.

The certificate for the Russian GOST standard is usually valid for 3 years. The validity of the certificate can be extended further.

Ascent EMIRATES is a leading consultancy for the GOST R certification in Dubai. It comes with twenty two years of experience in successfully consulting various organizations around the world. Ascent EMIRATES also has its presence in Sharjah, Abu Dhabi, Ras-al Khaimah, Ajman, Al Ain and Fujairah. It has an enormous network of experienced consultants and has been involved in thousands of successful certifications throughout the world. It helps an organization in understanding the certification requirements.

Ascent EMIRATES provides an improvement in services and relationships within and outside the organizations. It keeps transparency to the clients and also advises them on the ways to improve. It works with large organizations as well as SMEs. Ascent EMIRATES, through its effective advisory, helps organizations to cut down the GOST R certification cost in UAE. It also trains personnel within the organization on the conformity needs and procedure of certification.

So, to obtain GOST R certificate in Dubai, for your product, contact Ascent EMIRATES.

Outstanding success in achieving ISO certification

Outstanding success in achieving ISO certification

With the population of the world increasing day by day, there is a growth in the business field too. And with this increase in trade, a lot factors are coming into play that may pose as trouble to businesses and organizations. So, to control these, various certification procedures have been introduced by different regulatory bodies like International Organization for Standards (ISO) and others. The ISO certification along with other certifications, not only deals with the problems, but also, they enhance the transparency and credibility of an organization.

Ascent EMIRATES is one of the leading ISO consultants in Dubai. It has a reputation for effective interpretation, implementation and certification of an ISO standard. It is based in Dubai and comes with twenty-two years of rigorous experience in successfully consulting varied industrial segments over the globe. Ascent EMIRATES also has its presence in Abu Dhabi, Sharjah, Ras-al Khaimah, Ajman, Al Ain and Fujairah. It has an enormous network of experienced professionals and has witnessed thousands of successful certifications throughout the world.  Ascent offers simple & lucid ways to certification of ISO in Dubai. It provides an enhancement in services and relationships within & outside the organizations. Ascent EMIRATES keeps transparency with the clients and also advises them on the opportunities to improve. It offers a proper understanding of the standard. Ascent’s team of qualified professionals provide every information and knowledge required in order to assist the inspection body in acquiring the certificate of accreditation. Ascent EMIRATES works with large organizations as well as SMEs. Customer welfare is the top priority for Ascent EMIRATES. It utilizes available resources to cut down the cost making processes more cost-effective. Ascent EMIRATES, through its effective advisory, helps organizations cut-down the cost of ISO certification. It also trains personnel within the inspection body on the conformity needs and accreditation procedures. In UAE, while searching for ‘ISO consultants near me’, look for Ascent EMIRATES.

Ascent EMIRATES offers a plethora of ISO certifications which include ISO 9001 (for quality management), ISO 14001 (for environmental management), ISO 45001 (for occupational health and safety), ISO 10002 (customer satisfaction), ISO 22000 (for food safety), ISO 27001 (for information security management), ISO 21001 (for educational organization management), ISO 17025(competence of testing and calibration laboratories), ISO 13485 (medical devices quality management system), ISO 37001 (anti-bribery management system)  and so on. It also offers product marking certifications like CE Marking, GOST R, and UKCA marking and so on. Ascent also provides FSC Certification and BIFMA certification.

So, to get certified with any ISO, Dubai or somewhere in UAE, contact Ascent EMIRATES.

 

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