International Regulatory Compliance

Medical and pharmaceutical sales often go beyond borders. Thus, compliance with international regulatory measures is critical for any company, especially if they have locations outside the United States. 

Medical devices and effective pharmaceuticals don’t have borders. Ensuring compliance across international regulations is critical for any company, especially for those with global distributors and producers.

Here are some of the key international compliance measures QualityHub can address:

European Medical Device Regulation – EU MDR

 The implementation date for the European Union (EU) Regulation 2017/745, the EU Medical Device Regulation (EU MDR) is May 26, 2021. Transitioning to the EU MDR is just the first challenge.  The next is initial certification to EU MDR by your Notified Body and finally sustaining this certification to ensure uninterrupted access to the EU market.

QualityHub has EU MDR Subject Matter Experts that can help your organization meet these challenges. Contact us to discuss your transition strategy and learn how we can help you meet the challenges of compliance in a  complex global regulatory environment.

We can provide assistance in three areas:

Transitioning to EU MDR

• Establishing a Regulatory Compliance Plan for EU MDR Transition

• Gap Assessments of the Quality Management System and Technical Files for EU MDR

• Gap Assessments for Risk Management Programs for EU MDR compliance

• Development of Post Market Surveillance Plans

• Implementing Quality Management System Changes and updates for EU MDR

• Building Technical files for EU MDR

• Preparing for UDI Labeling and Registration

Preparing for Conformity Assessment and Certification by Your Notified Body

• Determination of Device Classification

• Developing a Regulatory Plan for Conformity Assessment

• Selection and Documentation of the Conformity Assessment Pathway

• Pre-Certification EU MDR Audits

• Completing the Declaration of Conformity

Sustaining EU MDR Compliance

• Routine EU MDR Compliance Audits

• Assistance in writing Post Market Clinical Follow-Up Reports (PMCF)

• Development of Post Market Surveillance Reports (PMSR)

• Development of Periodic Safety Update Reports (PSUR)

• Trend Analysis

• Vigilance Reporting

Medical Device Single Audit Program (MDSAP)

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities to audit under MDSAP requirements.

The MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States. The program’s main mission is to “…jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.”

We can provide assistance in these areas:

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