Quality Management System (QMS) Consultants for medical devices specialize in assisting companies in establishing, implementing, maintaining, and improving quality management systems specific to the medical device industry. Engaging proficient Quality Management System Consultants is crucial for medical device companies to ensure compliance with regulatory requirements, enhance product quality, and maintain the highest standards of safety and effectiveness for their devices. Get in compliance with QMS for your medical devices with the help of Operon Strategist.

QMS Certification Services for Medical Devices

QMS is a pivotal phase for an organization. QMS is an integral and important part of medical device manufacturing. As a medical device manufacturer, it’s the responsibility of the manufacturer to ensure the safety of the medical device which they are placing on the market. Our team provides training and guidance for the proper QMS implantation to manufacturers.

What is QMS-Quality Management System?

Quality management system is a structured process which contains all aspects of design, manufacturing, clinical data, risk management and more. one can say that QMS is a tool. The objective of QMS is to improve the quality of products and related services and regulations. When we talk about international markets like the US and Europe, ISO13485 standards & US FDA’s Quality system regulation i.e 21CFR part820 should be considered. We as ISO 13485 medical device consultant guide our clients about the documents & the correct implementation process needed.

Why Quality management system is important for organizations?

A QMS process helps to coordinate and direct the organization’s activities and to meet customer’s regulatory requirements and to make it effectual and improve its efficiency on a continuous basis.
Implemented and maintained Quality Management Systems have the power to affect all aspects of the organization’s performance.
QMS process is a set of policies or procedures mainly needed for the planning or execution of the business or in the organizations.
The documentation of the QMS process is to be maintained and controlled, that can impact the organization’s ability to meet the customer’s requirements.

The conventional methodology for building up a quality management system is that of tending to compliance to guidelines – once in a while bringing about direct forth of requirements characterized in ISO 13485: 2016 and other quality system requirements and regulations.

Types of QMS for Medical devices:

Different certification services in QMS includes ISO 9000 series (counting ISO 9000 and ISO 9004), the ISO 14000 series (ecological administration frameworks), ISO 13485 (quality administration frameworks for medical devices), ISO 19011 (inspecting the executives’ frameworks), and other.

ISO 13485 Certification: QMS ISO certification is the world acknowledged standard by the International Standards Organization for medical device quality management system. It can be used by any company involved in the transfer of medical devices. This specifies the requirements for a QMS certification. ISO 13485 certification for medical devices is a Quality management system required for regulatory purposes which is an ISO standard. ISO 13485 Medical Device Consultant specifies requirements for a Quality Management System (QMS) certification where an organization needs to demonstrate its ability to provide medical devices.

ISO 15378 Certification: This QMS certification is for packaging materials, for medicinal and pharmaceuticals products. Primary packaging materials for medicinal products which meet customers’ requirements as well as regulatory requirements and international standards relevant to primary packaging medicinal materials. ISO 15378 Certification is QMS certification for primary packaging materials for medicinal products particular requirements for the application of ISO 9001:2008, with reference to GMP.

ISO 9001 qms certification: is a globally required standard to describe the requirements of a quality management system in all industries. ISO 9001:2015 provides effectual risk assurance-based Quality Management System.

US FDA 21 CFR Part 820 Quality System Regulations: This process covers the facilities and control used for the design, manufacturing, packaging, labelling, storage, installations for medical devices – 21 CFR part 820

21 CFR Part 210 & 211 Quality Assurance: 21 CFR Part 210 and 211 Process deals with manufacturing, packaging, or holding if drugs and pharmaceuticals.

Every component of a quality management system accomplishes the general objectives of meeting the clients’ and association’s needs. The common elements of QMS can be:

The organization’s quality arrangement and quality goals

Quality manual
Consumer loyalty from item quality
Quality examination

What is Quality Management System certification?

Quality Management Systems (QMS) certification is the requirement of every business process who needs to comply with an arrangement of complex and challenging regulatory requirements. QMS is defined to help streamline and reinforce the internal process, or procedure. The QMS certification is a planned method for customers to receive what they expect and it is necessary to implement the quality system. In April2019 SFDA published a guidance document to help medical device manufacturers to implement ISo13485:2016 in their QMS.

How to get QMS certification?

To get the Quality management System certificate you need to implement QMS according to applicable ISO standard and set up the QMS so that the auditors can audit it and certify it. To implement QMS according to ISO you need an experienced medical device consultant who can train and guide you about the QMS.

What do (QMS) Quality Management System certification consultants do?

QMS consultants determine the design stages, validate the documents, provide training and guide organizations to attain the standards of quality, quality control, quality system and quality management. According to SFDA rule the regulatory authority will perform a rigorous assessment of documents submitted by the entity. These consultants assist manufacturers in auditing processes so that they easily get the certificate from the regulatory authority. The audit of the QMS of establishment and overseas manufacturer shall take place before the SFDA authorizes the devices to be placed on the KSA market.

What is our role as QMS certification consultant?

As QMS certification consultants we analyze the problems & issues which bother clients. As a medical device regulatory consultant Our QMS consulting services include layout designs, QMS certification training, manufacturing process and regulatory approvals. We have an experienced team who is having good hand in auditing, executing and maintaining all features.

our team involves in U.S. FDA, EU notified bodies, QMS certification body. We have well-built technical expertise to assist and protect your quality systems that can follow with the toughest regulatory inspection.

Our Country-Wise Quality Management System Certification Services Include:

US FDA 510k: This signifies that the device which is to be marketed is safe, effective and substantially equivalent to the legally marketed device. We are FDA 510k Clearance consultant & Help the clients to register SBU (Small Business Unit), if applicable. Resolving the queries and after completion of all the activities, the client receives the US FDA 510 k approval.

DMF: Drug master file is a document that is prepared by the medical device and primary packaging manufacturers in which they provide information about the product to the US FDA. We assist you in the preparation and submission of all types of Drug Master Files (DMFs).

CDSCO: Central Drugs Standard Control Organization, CDSCO comes under DCGI that is Drug Controller General of India. CDSCO regulates the medical device in India, under the provisions of drugs and cosmetics acts 1940 & rules 1945. The Applications for all classes are submitted to Central Licensing Authority, where the DCGI takes the responsibility of Manufacturing, registration, import and sale of medical devices in India. We Provide consultation on wholesale license for medical devices in India – CDSCO Registration

CE marking: CE mark certification is regulatory approval for the European market. The products having a CE mark declares that the product which is to be marketed meets all the relevant European medical device directives. We’ll help to test the product, to the creation of the technical file, and resolving all the queries after completion of all the activities. As CE mark Medical device for medical devices we’ll help you for the process of making a defined technical file with all the product details. We will help you in meeting European submission standards that state the product offered is in compliance with the exact requirements of European safety.

What are the benefits of QMS?

QMS is important to build trust as a design or as manufacturing company.

It improves processes and increases efficiency.
It ensures the consistent quality of products and services.
It helps to build a reputation and it creates trust among the customers.

Why choose Operon Strategist for QMS certification?

Operon Strategist has substantial experience in regulatory areas required for Quality Management System certification implementation of medical devices, in vitro diagnostic devices, packaging material products, pharmaceuticals products and combination products. We have handled national as well as international projects and Our presence in Saudi Arabia proved ourselves best. The team of Operon strategist can cope with the questions like Which QMS standards are applicable? What are QMS certifications? Requirement of QMS? What is compliance and certificate assessment? Etc.

All these questions and doubts can be successfully and easily solved with our experienced team which makes justice to your time and money.

Frequently Asked Questions : (FAQ’s)

What is QMS Service?

These are the set of policies and procedures which enable organizations to identify, control and improve business processes which leads to improved business performance.

Which ISO covers a quality management system for medical devices?

For medical devices, the Quality Management System is implemented according to ISO13485 standard.

What are the benefits of QMS?