ISO 13485:2016 sets out criteria for a quality control program where a company needs to demonstrate the ability to provide medical devices and related services that regularly meet consumer and regulatory requirements applicable. Such organizations may be involved in one or more stages of the life-cycle, including design and development, production, storage and delivery, installation or maintenance of a medical device, and the design and development or provision of related activities (e.g. technical assistance). ISO 13485:2016 can also be used by suppliers or external parties providing the product to these organizations, including services relevant to the quality management system.
ISO 13485:2016 standards apply to organizations irrespective of their size and form except where expressly specified. Wherever specifications are defined as being applicable to medical equipment, they apply equally to related facilities as offered by the organization.
In the medical device industry, ISO 13485 is simply a QMS, which is why it is sometimes known as 'MD QMS.' ISO 13485 certificates assure potential customers and stakeholders that a product was developed in compliance with the globally accepted standard ISO 13485. ISO 13485 Audit by CDG ensures that an organization meets all ISO 13485:2016 guidelines and that is why CDG is a trusted ISO 13485 certification company in the industry.
Whether you're looking to work globally or grow locally, ISO 13485 Certification will help you boost quality efficiency, reduce confusion, and increase opportunities for the market. Organizations with this certification advise both consumers and regulators of a commitment to quality.
a. Enhance market access worldwide
b. Specify how to review and improve processes around the business
c. Improve efficiency, cut costs, and track performance in the supply chain
d. Demonstrate that you manufacture medical devices that are safer and more efficient
e. Meet regulatory and customer expectations
f. ISO 13485 increases the performance of the medical devices business or its product and process
g. ISO 13485 is universally recognized and covers regulatory and statutory requirements in most countries the company has spent access to the market
h. ISO 13485 works as a brand ambassador for your medical devices and will, therefore, reduce your sale & marketing costs.
STEP 1 Apply for ISO 13485:2016 certificate by submitting the application form filled out in ISO 13485 (soft or hard copy).
STEP 2 Our ISO 13485 auditor/specialist will review the application form and will issue a quote for ISO 13485 certification if approved.
STEP 3 Upon submission of the ISO 13485 certification fee, we will send you the ISO 13485 audit plan (stage 1) and audit will be conducted thereafter.
STEP 4 CDG will send you to stage -2 ISO 13485 Audit Plan after successful stage-1 audit closure of the NC's (if any). After a successful audit, the auditor will recommend an ISO 13485 certification for your organization.
Documents required for certification
a. Quality Manual
b. Responsibility and authorities
c. Medical devices file
d. Procedure for design and development
e. Document control procedure
f. Training Procedure
Processing of certification may take 30 working days to get complete
Call or WhatsApp us on +91-99991-39391 for free consultation from our team of experts. You can also email us on firstname.lastname@example.org.
We share the detailed and reasonable estimated costs, documents and prerequisites for the complete process before starting the process to ensure transparency.
Our team warrants hassle free documentation. We collect the necessary documents and share the relevant drafts to ensure a timely filing and delivery.
Upon collecting the necessary documents and information, we waste no time in preparation and filing of your application. development on your application is brought to your attention.
On successful completion of the case we share all the relevant documents electronically and physically along with an assurance to pay you back if something is wrong.
ISO 9001:2015 specifies the quality management system requirements when an organization is involved: A) Must demonstrate the ability to consistently offer customer fulfilling goods and services and the relevant legislative and regulatory requirements;Read More
ISO 13485:2016 certification ISO 13485:2016 sets out criteria for a quality control program where a company needs to demonstrate the ability to provide medical devices and related services that regularly meet consumer and regulatory requirements applicRead More
ISO 14001:2015 specifies the environmental management system requirements that can be used by an company to enhance its environmental efficiency. ISO 14001:2015 is intended for use by an organization seeking to systematically manageRead More
ISO food safety management standards help organizations identify and control hazards to food safety while working with other ISO management standards, such as ISO 9001. Applicable to all types of manufacturers, ISO 22000 provides a reassurance layerRead More
An Occupational Health & Safety Management System, also refers to as OH&SMS, comprises of regulations, procedures, strategies, activities, and records that describe the rules governing how the company takes care of workplace safety and health.Read More
Halal mean permitted or lawful, it is a Arabic term used in Muslim Holy book. According to this it is responsibility of a muslim to ensure that any food consumed or any businesses performed in their daily lives are clean, hygienic and not detrimental to eRead More
Kosher is a Hebrew word meaning "fit" or "healthy." If "kosher" is applied to food, it means that a food item is prepared for consumption under Jewish law, while the term "kashrus" refers to the general subject matter of kosher food. Complete separationRead More
A HACCP system allows you to identify hazards and have controls in place to manage these during production throughout your supply chain. The HACCP scheme meets the Codex Alimentarius Commission (CAC) criteria developed by the World Health OrganizationRead More
The Agmark certification acts as a consistency benchmark and is similar to vouching for product authenticity. Agmark is regulated by 1937 (as amended in 1986) Agricultural Produce (Grading and Marking) Act. Currently, Agmark Standards cover around 222Read More
The ANSI accreditation mark is a symbol of excellence that employers, business executives, hiring managers, and certification holders worldwide recognize. After its introduction in 2003, the personnel accreditation system of ANSI based on the internationaRead More
Bespoke advisory focused on mission critical legal, financial and business aspects.
Uniquely repurpose strategic core competencies with progressive content. Assertively transition ethical imperatives and collaborative manufactured products.Write About Us
Professional and trusted service, my company needed certification from the state excise in the State of Telangana and CORPZo were so professional in their approach, be it filing of part 3 and 4 of MSME or application process with the state exice that it made my life easy.
Will always look to a team which is knowledgeable particularly when it comes to the field of alternative medicine. I had spoken to many including the government offices but was confused how to proceed with setting up of my pharma unit, CORPZo had the right professional guidance available.
They believe in transparency in business and give high regard to Customer Satisfaction. Love to work with them and Highly Recommended
I needed to apply for business related registration and receive some certificates. Their service is very professional. I researched in the market and found that they are very cost effective, so initially I was a bit doubtful, but, for my surprise, they are better than some of the big house.
Awesome and excellent services provided to me. Great and polite gestures with full professional behavior . Have got my company incorporated by corpzo. It was done within a week and have been using their accounting services ever since. They have been a real boost to my business.
© 2023 Corpzo Ventures Private Limited.