To ensure InteRA is a good fit for your needs, simply listed below are some of our key capabilities.

Systems

ISO 13485,
ISO 9001,
US FDA 21 CFR part 820,
MDSAP
CMDCAS,
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

Support

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

European

EU (CE) + Non-EU registrations

America’s

US (FDA), Canada (Health Canada)

Latin America:

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.
India (CDSCO)
China (CFDA)
Russia (Roszdravnadzor)

Other

+ 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.

Contact Us

+44 (0)1626 330151

+44 (0)7979 105 763

mail@interaconsultancy.co.uk

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