Medical Device Services

Proven methodology for long term success

Confidence Beyond Compliance

Safis MDS leverages over 20 years’ Medical Device experience and expertise coupled with proven methodologies and hands-on support to optimize and customize our QA/RA services for our clients. Our comprehensive QA/RA services portfolio addresses compliance needs throughout the product lifecycle.

  • Regulatory Consulting – both pre- and post-market regulatory services, including regulatory agency correspondence / interactions.
  • QA and Compliance Consulting – primarily relating to Quality Management System development and implementation and monitoring (including auditing).
  • Remediation Consulting – start-to-finish leadership and support for product and process remediation – including regulatory agency correspondence / interactions.
  • Outsourcing – complete outsourcing offerings including U.S. Agent/Official Correspondent services and interim QA/RA staffing.
Ask the Experts

Ask The Expert

Need a quick QA/RA consultation? We’ll respond within 72 hours.

US Agent

US Agent

Want to enter the US medical device market? We can help.

Inspection readiness

Inspection Readiness

Need short explanatory copy here

EU MDR

EU MDR

Ensure you are prepared for the changes to the EU MDR in Spring 2020.

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Partnering to bring innovative products to market and improve overall healtcare

  • Pre-Market RA:  From Product Development to Market Authorization
  • Post-Market RA:  After Product Market Authorization

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Optimize your Quality Management System (QMS)

QA and Compliance Consulting:  From Planning through Implementation and Maintenance/Monitoring

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Product – Process – Culture

Remediation Consulting:  END to END Leadership and Support Services for Remediation.

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Optimize and Reduce Costs while Growing your Business

Outsourcing Services: Customized to your needs

Safis are experts with many years of experience within the Medical Device Industry and can supply fully outsourced services to increase efficiencies and effectiveness.

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PharmaLex and the Johner Institute have entered into a partnership to provide added value to our clients. Alongside our existing service portfolio, we can provide support with the help of the Johner Institute on:

  • Software Development Compliance
  • Risk Management
  • Cybersecurity Requirements
  • Usability Studies

What our clients say

We needed to develop our strategy and PharmaLex had exactly the experience we needed.

Med Device company, UK
Senior QA Director

We needed a partner to help us obtain device approval. PharmaLex have not only helped us achieve this but are now providing on-going post-marketing surveillance support. We would highly recommend them to anyone who needs specialist expertise.

Med Device company, US
Senior Regulatory Affairs Director