To ensure InteRA is a good fit for your needs, simply listed below are some of our key capabilities.
- ISO 13485,
- ISO 9001,
- US FDA 21 CFR part 820,
- Korea KGMP
- Medical Device Directive (MDD)
- Medical Device Regulation (MDR) gap analysis, and planning for.
Technologies & Specialisms
- Sterilisation validation (Gamma Irradiation and EtO Gas)
- NPI planning, Product Tests & Validations
- Biocompatibility study planning
- Packaging stability study planning
- Medical devices used in Open / Laparoscopic / Gynae surgical procedures.
- Accessories and consumables used within healthcare environments.
- HF surgical accessories
- Procedure packs
- Single use and re-usable devices
- Quality and Regulatory training
- Health Authority/Notified Body audit preparation and assistance
- Vendor / Distributor, Regulatory management.
- Essential Requirement review, Risk Analysis, and Clinical Evaluation Reports
- Technical File generation
- CAPA and PMS/Vigilance management
- Instructions For Use, Labelling and UDI
Market Entry Regulations & Registration Applications
EU (CE) + Non-EU registrations
US (FDA), Canada (Health Canada)
Brazil (ANVISA), Mexico (COFERPRIS), Peru (DIGIMED), Columbia (INVIMA), Argentina (ANMAT), Venezuela (OICEMP)
Middle East & Africa:
Saudi Arabia (SFDA), Bahrain (NHRA), UAE (MoH), Qatar (MEC), Egypt (CAPA), Turkey (MoH), South Africa (MCC)
Asia & Pacific:
Korea (KFDA), Japan (MHLW – PMDA), Australia (TGA), New Zealand (Medsafe –WAND) and ASEAN member countries with CSDT applications process.
+ many others – please enquire
We'd love to hear from you...
For initial discussions on any service requirement that you wish InteRA to assist with, please do not hesitate to get in touch. We look forward to hearing from you.