Quality Management System

Quality Management System

A core competency of confinis lies in the construction of quality management systems according to EN ISO 13485, and 21 CFR Part 820, respectively, for the US market.

A quality management system consists of procedures that are implemented in clearly structured SOPs (Standard Operating Procedures) and associated templates (checklists, forms, etc.).

The key component to keep these processes organized is the quality manual. It forms the basis for a successful quality management system certification according to EN ISO 13485. A certified management system not only helps obtain a successful product certification but also guarantees increased transparency of the various business processes and thereby significantly reduces error rates.

We conduct the necessary processes according to the relevant standards and tailored to your company’s activities. In addition, we define the process ownership and set the interface for other processes. Defining the KPIs (Key Performance Indicators) helps monitor the effectiveness of the implemented processes.

What is it?

A quality management system consists of interconnected processes with respective SOPs and templates.

All services

Since the publication of 21 CFR Part 4, we have supported numerous customers proactively in the implementation of appropriate requirements.

One of confinis’ key competencies lies in the design control procedure for medical devices and combination products.

Risk management is a central process throughout the development and the entire product lifecycle. We help create a complete risk management file by combining risk management with usability engineering/human factors and additional normative requirements.

The usability engineering procedure is closely linked to the risk management process.

confinis can create a clinical evaluation for your medical device, which is required for regulatory purposes or can help you define and implement relevant internal procedures.

Knowledge and experience from confinis concerning combination products are globally unique and make confinis a valued partner.

We are happy to support you with our experience in developing the right packaging for your products and customers.

Nothing simply Improves on its own, but you can actively make everything better – confinis will gladly assist you to increase your added value!

We determine for our customers how the relevant app is classified in different markets and what effects this will have on the development, testing and documentation.

One of confinis’ key competencies lies in the design control procedure for medical devices and combination products.

Risk management is a central process throughout the development and the entire product lifecycle. We help create a complete risk management file by combining risk management with usability engineering/human factors and additional normative requirements.

The usability engineering procedure is closely linked to the risk management process.

confinis can create a clinical evaluation for your medical device, which is required for regulatory purposes or can help you define and implement relevant internal procedures.

We help our customers compare the relevant technological and regulatory requirements with the current status and assess the situation.

Knowledge and experience from confinis concerning combination products are globally unique and make confinis a valued partner.

confinis has years of experience from the soft improvement up to the complete remediation of development documentation of various medical devices, the so-called Design History File (DHF).

confinis gladly supports you with risk-based, efficient implementation of the normative requirements and combines these with a suitable software development procedure.

We support the manufacturers with the implementation and set-up of the relevant processes. This could be general procedures or product specific postmarket surveillance plans.

Our goal is to prepare your team until they know that they will succeed and look forward to prove their competences.

confinis has years of experience with the risk-based and efficient validation of manufacturing processes in regulated environments.

confinis uses trained auditors that clarify processes and point out improvement potential.

We will gladly work on a training concept with you and develop a training process tailored to your company’s size and existing knowledge.

A core competency of confinis lies in the construction of quality management systems according to EN ISO 13485, and 21 CFR Part 820, respectively, for the US market.

One of confinis’ key competencies lies in the design control procedure for medical devices and combination products.

The implementation of various requirements of the national authorities often represents major challenges to the international distribution of medical devices and combination products and requires extensive know-how of country-specific requirements. Market authorizations in target markets are coordinated with the help of the Regulatory Affairs Strategy.

confinis has extensive experience in developing suitable, regulatory-compliant strategies for attaining CE-certification, which is necessary for the introduction of medical devices in the European Union.

The employees at confinis have substantial knowledge regarding the regulatory approvals of medical devices in the US.

Our consultants at confinis can support you with their experience of product approvals in Asia, South America, etc.

Manufacturers of medical devices that are located outside of the EU and its contracting countries (such as Switzerland), require an agent (also known as an “Authorized Representative”). confinis can assume this function for you.

Foreign manufacturers of medical devices, including key suppliers, who wish to sell their products in the United States must designate a “U.S. Agent” residing in the US. We are able to fill that role and act as a U.S. Agent for you.

We are confinis. How can we help you?

Call us at a confinis office nearest to you or send us a message online.

We are very happy with our choice of confinis as a one stop shop QA/RA partner to Neo Medical, supporting our growth from a start-up to an international company. confinis has provided expertise in everything from quality management, design control, clinical evaluation, internal and supplier audits, CE marking, 510(k)s to global registrations. I highly recommend confinis!

Jonas Larsson
CEO, Neo Medical

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