Global – Prepared – Compliant

MDSAP support for international medical device markets

Prepare your QMS for the Medical Device Single Audit Program (MDSAP) in international markets.

MDSAP Readiness

Identify any system gaps before your formal audit and understand where your existing QMS needs to be strengthened.

International Requirements

Integrate applicable country-specific regulatory requirements alongside your ISO 13485 Quality Management System.

Audit & Remediation Support

Experienced support before, during and following MDSAP audits, including preparation and corrective action.

Expanding into international
medical device markets?

MDSAP provides a framework through which a recognised Auditing Organisation can conduct a single regulatory audit, against the requirements of multiple participating regulatory authorities.

Build on ISO 13485 while incorporating additional requirements:

  • MDSAP readiness and gap assessments

  • QMS review against the MDSAP audit approach

  • Country-specific regulatory requirements

  • Audit preparation and staff readiness

  • Mock audits and evidence reviews

  • Audit finding and CAPA remediation

One audit framework, multiple regulatory requirements

MDSAP is designed to allow participating regulators to make use of the results of a single quality-system audit while retaining their own national regulatory requirements.

This creates an opportunity for manufacturers operating across several markets to take a more coordinated approach to regulatory compliance. However, it also means that the QMS must appropriately address the additional requirements that apply in each jurisdiction included within the manufacturer’s scope.

We can help review the way these requirements are incorporated into your existing Quality Management System and identify areas where procedures, records or regulatory processes may need strengthening.

  • Map applicable requirements against your existing ISO 13485 processes and identify where additional controls are needed.
  • Review objective evidence across areas such as management responsibility, design, production, CAPA, complaints, adverse-event reporting and regulatory processes.
  • Prepare your team for the audit approach, helping process owners understand what evidence may be required and how different elements of the QMS connect during an MDSAP assessment.
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Approach with confidence and comfortability

MDSAP audits can be demanding because auditors are assessing both the effectiveness of your Quality Management System and compliance with the applicable regulatory requirements of the markets included within the audit.

Preparation therefore needs to go beyond making sure procedures exist. Your organisation must be able to demonstrate that processes are implemented, records are available, responsibilities are understood and country-specific requirements have been appropriately addressed.

We can conduct an independent readiness review, work through the MDSAP audit approach with your team, identify potential weaknesses and help prioritise actions before the formal audit.

Where non-conformities are raised, support can continue through investigation, root-cause analysis, corrective action and preparation of the evidence needed to demonstrate effective remediation.

Additional International Regulatory Support

MDSAP may form part of a wider international regulatory strategy. We can also support manufacturers working towards market access and ongoing compliance in the United States and Great Britain.

FDA Support

For manufacturers entering or operating in the United States, we can provide practical support in understanding and preparing for relevant FDA medical device requirements.

  • FDA regulatory readiness and gap reviews
  • Device classification and applicable regulatory pathway support
  • Quality Management System Regulation (QMSR) readiness
  • Preparation for FDA inspections
  • Review of quality-system documentation and objective evidence
  • Support with remediation following identified compliance gaps

UKCA / MHRA

We can also assist manufacturers preparing medical devices for the Great Britain market, including support with the applicable UK medical device regulatory and conformity-assessment requirements.

Medical devices placed on the Great Britain market are regulated by the MHRA, with specific conformity-assessment and marking requirements depending on the device and applicable route.

Note: Different rules apply in Northern Ireland.

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