Asessment and Certification of Companion Diagnostics (In-Vitro Diagnostics)

Companion diagnostics (CDx) are typically developed in close collaboration with drug development companies to support doctors in selecting or excluding specific patients for treatment (personalized medicine). Providing practitioners with critical information on how a drug performs according to unique human biological traits of the patient, CDx can help predict positive and negative responses based on the personal characteristics of each individual patient, before being prescribed with a chosen therapy. Health care professionals increasingly rely on companion diagnostics to provide information essential for the safe and effective use of a certain drug or therapeutic products.

Our experts will provide conformity assessment of CDx products according to the new in-vitro diagnostic regulation (IVDR 2017/746). Replacing the 98/79/EC directive, the new IVDR came into force on 25th May 2017 and will be singularly applied as of 26th May 2022. These conformity assessments will include on-site audits of your quality management system (QMS) as well as reviews of your technical documentation.

As a first on your way to IVDR compliance, we can provide you with a QMS certification according to ISO13485 / ISO 9001 already today.

We have worldwide acting highly skilled experts and auditors who support your transition to the new regulation with their comprehensive knowledge in the field of companion diagnostics and conformity assessment procedures under the IVD directive 98/79/EC.

Certify your CDx products according to IVDR with our accredited services. Contact us now.

Pharma companies or medical device manufacturers benefit from our services by gaining insight into provisions of the new IVD regulation. We help you to comprehensively understand and effectively control CDx co-development projects with your CDx manufacturing partners.

Focussing on the transition period and timeline milestones for IVDR compliance, our comprehensive services help you successfully move from IVDD (in-vitro diagnostic medical devices directive) to IVDR to ensure your timely place on the European market.

As a regulation set in European law, IVDR assessment and certification is a mandatory benchmark requirement for CDx devices intended for the European market. Classified as risk class C, CDx devices are subject to a conformity assessment carried out by a Notified Body. After designation, we will provide you notified body assessment services according to the new IVDR:

• Conformity assessment of CDx products according to the new IVDR 2017/746
• On-site audits
• Product technical file review

We provide assistance for CDx manufacturers by ensuring a smooth transition from IVDD to the stringent and demanding provisions of the IVDR. Furthermore, we support IVD manufacturers with additional services such as ISO 13485 certification.

In addition to our comprehensive service package and extensive expertise in the area of personalized medicine/CDx.

Contact us to get more information!