Medical Device Services

Proven methodology for long term success

Confidence Beyond Compliance
Whether you need a few extra hands or someone to take the lead, Safis  employs experienced QA/RA professionals with expertise across the full domain. We can provide consulting and outsourcing services that are tailored to meet your needs.

  • Established in 2002 and expanded in 2017 as part
    of PharmaLex
  • Global QA/Compliance & RA Consulting and Outsourcing
  • Highly qualified QA/RA professionals with extensive Medical Device experience
  • QA/RA Learning Institute offers on-going education including client interactive workshops

End-to-End Product Offerings:  Customized to Client Needs

Choose from over 100 individual QA/Compliance & Regulatory Affairs (RA) service offerings.

QA / Compliance Consulting >>

  • Development of global compliance and improvement strategy
  • QMS development and improvement
  • Assistance with implementation of strategy across products, process and culture
  • Quality auditing
  • Implementation of key performance metrics
  • EU MDR 2017/745 and EU IVDR 2017/746 compliance including Technical File/CER updates

RA Consulting >>

  • Development of global regulatory strategy
  • Completion of regulatory strategy activities, including classification, pre-submission meetings and product registration submissions
  • Analysis of product changes to determine regulatory impact
  • Post-market surveillance activities

Remediation Consulting >>

  • Analysis of enforcement actions
  • Development of remediation plan
  • Execution of remediation plan, including leadership for work streams and CAPA
  • Regulatory agency responses/updates and interactions
  • Inspection readiness

Outsourcing Solutions >>

  • Drive business growth (including due diligence support)
  • Reduce cost and increase process effectiveness and efficiency (regulatory maintenance services, auditing services, employee training, recall management, regulatory intelligence monitoring)
  • “Right size” staffing (US agent/official correspondent, interim staffing)

End-to-End Product Offerings:  Customized to Client Needs

Choose a cost-effective solution that meets your needs from our predefined packages or customize your own.

Platinum-Gold-Silver or Bronze level packages available.

Choose the level of support that meets your needs — from assistance with basic project requirements to on-going assistance throughout the year.

Beyond training to learning!

Hands-on/Interactive Workshops

2018 Courses (1-2 day sessions)

  • Inspection Readiness
  • CAPA
  • CERs
  • Post Market Surveillance Reporting

On-site tailored coursework also available.

For Clients only

  • First Come – First Served
  • Free to first two client attendees
  • Minimal fee for each additional client attendee

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