SGB QA/RA Consulting Ltd. was launched in 2018 to provide a complete range of services to meet the compliance needs of medical device companies including SMEs and Start Ups.
We have over 25 years’ experience working with a wide range of medical device clients on many projects including:
- MDD to MDR Upgrade
- IVDD to IVDR Upgrade
- CE Marking for all classes of Medical Device incl. Software (SaMD)
- ISO 13485: 2016 Compliance
- Audit Remediation
- Market Access: 510k Submissions (US) / Canada / Australia / MDSAP / ASEAN
- Internal Auditing
- FDA Warning Letters / Remediation
- Bespoke Remote / On-site Training
We can help with specific projects such as producing a Quality Management System (QMS) and Technical File to obtain your CE Mark or providing additional support for a remediation project following an audit.
We will discuss your project with you before producing a detailed, timed and costed project proposal for your consideration.
For many of our clients who require ongoing support (often for only a few days a month) we offer bespoke outsourced support. With a fixed monthly fee our clients can call on an agreed time bank which can be used flexibly whether for consultancy, project delivery or remediation work.
We can assist in providing tailored in-house training to your team members including the latest regulatory changes (MDR, ISO 13485:2016 etc), performing basic QA/RA tasks (internal audits, CAPAs etc) or bespoke training to help develop your staff.
We offer a free initial phone or video consultation to meet you, understand more about your business and how we might be able to help…