The Regulatory Strategists

OUR VISION

WE PROVIDE CLARTIY AND GUIDANCE FOR CONTINUED MARKET ACCESS

OUR COMMITMENT

IS TO PROVIDE TRAINING AND SUPPORT TO THE MEDICAL DEVICE INDUSTRY.

OUR MISSION

IS TO HELP YOU DESIGN YOUR STRATEGY AND IDENTIFY ANY GAPS THAT KEEP YOU FROM IMPLEMENTING IT.

VALUES

WE SHARE A COMMON GOAL WITH OUR CUSTOMERS WHICH IS TO CREATE A SAFER WORLD THROUGH COMPETENCE, COMMITTED ACTION AND CONTINUOUS LEARNING.

WE BELIEVE IN THE BEST GLOBAL PRACTICES AND SHARING KNOWLEDGE.

Regulations are constantly changing which is challenging for many organizations. Currently there is a lot of confusion due to the new MDR in Europe. Medical device manufacturers are required to meet the new European Medical Devices Directive (MDD 93/42/EEC) and have limited time left to comply. Currently we are therefore focusing on services such as a gap analysis and training to help you get ready.

MDR Gap Analysis

We provide guidance and a thorough analysis of your current Quality Management System

You will gain clarity regarding what actions to take toward MDR Compliance

We provide a one-on-one personalized approach customized to your needs taking into consideration your current system and required complexities!

MDR Training Modules

We will explain the new requirements in an on-line workshop with you and your team.

This will include a variety of modules that can be broken down to meet your needs and timelines.

The workshop will allow plenty of time to ask questions. This interactive approach provides a unique learning environment.

Regulatory Strategies

Not sure where to start regarding your regulatory needs or which countries to access first?

Schedule a free 30 minute call with one of our experts to gain more clarity. We will be happy to share some of the critical steps with you.

There are some basic global concepts we are happy to provide!

IVDR GAP-Analysis

Does your product now require a Notified Body?

Did you need to up-classify as a result of the revised In Vitro Diagnostics Regulation?

We provide support for your IVDR Transition Project with a thorough analysis of your current Quality Management System.
The Gaps towards IVDR compliance will be easily identified and you will be ready to take action.

Time is running out and there are few Notified Bodies.

Time is NOW to start your project and develop the competency to meet the new regulation.

Internal Audits/Supplier Audits/Pre-Audits

No time for internal audits or supplier audits this year?

We have experienced auditors ready and provide the necessary services in internal auditing and supplier auditing.

We ensure that all regulatory requirements are covered and that audits are adequately documented.

Our auditors also can help in getting you ready for your Registrar’s Audit with Pre-Audit Services.

ISO13485/ISO9001 Implementation

Compliance is critical in the medical device world in order to gain market access and to ensure safety of the consumers. Our experts can help you implement these standards and guide your way towards certification. We develop your quality manual, process documentation, conduct management reviews, internal audit training, and provide everything needed to be ISO 9001:2015 or ISO13485:2016 certified. If you already have systems that are meeting outdated version of the standard we will conduct the gap analysis and take you on the road to compliance. We also have on-line training modules available and offer customized training programs that will meet your resources and timelines.

What you need to KNOW:

When is the date of application for the MDR?

Europe’s Medical Device Regulation (EU) 2017/745 went into effect in May 2021 and as a manufacturer, authorized representative, distributor or importer you will need to get ready and comply. Depending on the expiration of your current certifications you might run the risk of not having market access. Start your project NOW to avoid any gaps in certifications.

My MDD certificate is still valid and I have plenty of time, right?

Actually, your quality management system should already be prepared for the additional Post Market Surveillance and Vigilance Reporting Requirements. Economic operators need to register into Eudamed and procedures should be updated to reflect the new responsibilities. Get a list of your required actions and let one of our experts help you get them done!

What about the IVDR?

There is even more pressure for our IVDR Manufacturers. There is only one year left until May 2022 to comply with the changed IVDR Regulation (EU) 2017/. All devices with IVDD certificates can no longer be sold or put into service. There are not many Notified Bodies yet with designations. Therefore it is imperative for IVD manufacturers to prepare right now.

Contact us for any further questions