Medical Device Compliance Assurance Services

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® Inc. can help.

 

Our team of 500 FDA veterans and industry professionals offers a unique blend of expertise that allows us to handle both simple and complex regulatory compliance challenges within the medical device industry. We provide a range of Medical Device Compliance Assurance services, including:

 

Assessments

One of the best ways to avoid a compliance crisis is through prevention — and we have the expertise needed to help. RCA’s quality and compliance consulting professionals can identify and assess any outstanding issues and deficiencies to plan an ideal compliance solution. Our variety of assessment services includes:

 

  • Quality infrastructure
  • Maintenance and facility
  • GMP, ISO, CAPA and PAI
  • Due diligence services

Audits

Conducting regular internal audits is an ideal way to ensure continual compliance with changing FDA, ISO and internal standards and regulations. At RCA, we have comprehensive experience in providing both targeted and extensive audits to cover a range of compliance concerns. Our ASQ-CQA and Exemplar Global certified audit professionals are available to assist you with auditing services such as:

 

  • GMP Part 820 and ISO 13485 quality systems
  • Internal
  • Supplier
  • Pre-approval
  • Contract manufacturer

Preparation and Training

If you’re preparing for an FDA inspection, you’ll need to do more than just hope for the best. RCA helps you thoroughly prepare for your next inspection with tools like mock inspections, facility preparation and staff training. Feel ready and confident for inspection day through RCA services such as:

 

  • Front and backroom logistics and management
  • Facility tour preparation
  • Mock inspections and gap assessment
  • Personal behavior coaching
  • FDA readiness inspections

Regulatory Agency Action Response

We know that a compliance failure can have an immediate and lasting effect on your business, and we’re prepared to step into action immediately to help you navigate adverse findings during an inspection or an FDA warning letter. Our range of remediation services allows you to relax knowing that your business is in good hands.

 

Our expert team can assist in the preparation of a response to:

 

  • FDA form 483
  • Warning letters
  • Consent decrees
  • Import bans

Contact RCA for Quality and Compliance Consulting Services

Since 2000, RCA has helped thousands of medical device companies around the world to navigate the growing complexities and demands of the FDA and other regulatory authorities. We know that a compliance crisis can significantly impact your business, which is why we offer a unique blend of resources and training to best help you manage them. Whether you’re a local start-up or a Fortune 100 company, RCA is here to assist you with any concerns you might have surrounding your devices’ regulatory compliance.

Contact us using the form below for more information or to request a service.

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