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
  • Quality Management System (QMS) development and improvement
  • Assistance with implementation of strategy across products, process and culture
  • Quality auditing to applicable regulations (including 21 CFR Part 820, 803, 806, ISO 13485, GCP, ISO15189, CLIA, CAP, GLP, ISO 17025)
  • Implementation of key performance metrics
  • Updates due to changing regulations (including EU MDR 2017/745, EU IVDR 2017/746, MEDDEV 2.7/1, Rev 4)
  • MDSAP gap assessment/preparation
  • Inspection/Audit readiness

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 and 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 >>

  • US Agent/FDA Official Correspondent Services
  • Staff Augmentation for interim staffing needs
  • Regulatory Maintenance Services: including site registrations, product listings, export certificates, import clearances, product labeling reviews, technical file/CER updates, post-market surveillance reports
  • Due diligence support for acquisitions
  • Complaint Handling and Recall Management

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

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

Need a quick QA-RA consultation? Send your questions to meddevice@pharmalex.com and our expert QA-RA team will review your inquiry and provide feedback within 72 hours.

Frequently Asked Questions

  1. Is the product we are developing a medical device?
  2. How do we determine the classification for our device?
  3. Can we utilize the 510(k) regulatory pathway for US market authorization?
  4. How do we register our facility and list our products with the FDA?
  5. What is required to be on product labeling?
  6. Do you provide services for U.S. Agent/Offiical Correspondent?
  7. How do we prepare for an FDA inspection?
  8. What procedures are needed to implement a compliant quality system?
  9. What is the best approach for complying with new EU MDR requirements?
  10. What is the best way to respond to an FDA 483 and how do we address remediation?

US Agent / FDA Official Correspondent Services

Are you looking to enter the US medical device market? Do you need an in-country representative? We can help you reach your business goals.

We can serve as your US Agent
The US agent must either reside in the U.S. or maintain a place of business in the US. The US agent cannot use a post office box as an address. The US agent cannot use just an answering service. They must be available to answer the phone or have an employee available to answer the phone during normal business hours.

The responsibilities of the U.S. agent are limited and include:

  • assisting FDA in communications with the foreign establishment,
  • responding to questions concerning the foreign establishment’s devices that are imported or offered for import into the United States,
  • assisting FDA in scheduling inspections of the foreign establishment and,
  • if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.

Please note that the U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E).

We can serve as your FDA Official Correspondent
An official correspondent is defined as:

  • The person designated by the owner/ operator of an establishment responsible for the annual registration of the establishment and the device listing. The official correspondent also receives correspondence from the FDA involving the owner/operator and any of the firm’s establishments.
  • The official correspondent is responsible for the registration and listing information for each establishment to which he/she is assigned.
  • The official correspondent can:
    • Create new registrations and listings
    • Make changes, updates and cancellations to registrations and listings that have been assigned to them
    • Add their establishment(s) to listings previously entered for the owner/operator
    • View registration and listing information for the establishments which have been created by or assigned to them

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