Zero to ISO 13485 in 90 days

Let's Go

Is Your Wearable A Medical Device?

Get Your Design In Sync

Digital Health & Mobile Apps

Swipe It

IEC 62304 SDLC Solutions

New Epic Starts Here

Is your Aesthetic Product A Medical Device?

Shed Some Light Here

MDR/IVDR Transition

Get Ready

Zero to ISO 13485 in 90 days

Let's Go!

Is Your Wearable A Medical Device?

Get Your Design In Sync

“Digital Health & Mobile Apps

Swipe It!

IEC 62304 SDLC Solutions

New Epic Starts Here

Is your Aesthetic Product A Medical Device?

Shed Some Light Here

MDR IVDR Voyage Specialists

Get Underway

The CRO Group is a leading global consulting organization and service provider. We specialize in providing consulting services for Medical Device, In-Vitro Diagnostic, Over The Counter (OTC), Digital Health, Software as a Medical Device (SaMD), and Wearable product companies seeking FDA Approval/de Novo/Clearance, CE Marking, Clinical Studies, ISO 13485:2016, MDSAP, ISO 14971, IEC 62304, as well as other Clinical, Quality, and Regulatory services. We are also registered with FDA as an U.S. Agent.
We value our clients’ business and provide worldwide services.

Auditing

The CRO Group conducts internal audits, supplier audits, and mock FDA inspections and MDR/IVDR Notified Body audits for regulated industry clients. We also conduct due diligence audits for both pre-acquisition as well as VC/Angel review of potential investments. We perform ISO 13485:2016, MDSAP and MDR/IVDR pre-audits as well as QSR with Design Controls readiness audits for SaMD (Software as a Medical Device) product companies especially prior to FDA device listing and establishment registration.

For more information, click here.

Training

The CRO Group custom training programs for regulated industries run the spectrum from short seminars on a specific requirement to day-long courses on EU MDR/IVDR, ISO 13485:2016,  ISO 14971, IEC 62304 (integrating Agile/SCRUM development) as well as MDSAP or FDA QSR including Design Controls as applied to SaMD and or other medical device products with software.  Interested in one of these or a related regulation or standard?

For more information click here

Design & Development Consulting

The CRO Group provides consulting services acting as part of your engineering, clinical, quality and regulatory team. Please find our recent technologies and techniques along with our recent devices that we have worked with below.
For more information on our Consulting Services click here.

Recent Technologies & Development Techniques: Windows, Linux, QNX, iOS, Android, Real time Embedded Systems Smartphone and Tablet Apps, C#, Visual Studio/.NET, Photo-optical, AGILE & SCRUM
Recent Device types: Aesthetic Beauty, DICOM/PACS, Molecular Diagnostics, Surgical Robotics, Telehealth, Wearable Monitors.
If you do not find your device above please contact us here

Auditing

Training

Design & Development
Consulting

We have the expertise to accelerate your product development
and expand your business worldwide

Try Us, You’ll Like Us

Take the guesswork out of your Development and Regulatory plans so you can get back to what’s really critical – running your business. We’ve been working with Medical Device and IVD clients since 1996 – serving as trusted consultants and advisors for compliance and approvals.

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