| Regulatory Progress Associates
(RPA) specialize in
Medical Device and Pharmaceutical
regulatory. We also cover
other regulated products such as
cosmetics and natural health
products. Our extensive
experience with regulatory bodies
such as US FDA and Health Canada
ensures that you will follow the
correct path to establishing and
maintaining compliance with
regulations. Product Specialties
include:
- Implantable (artificial
knee, hip, screws, etc)
- Picture Archiving and
Communication Systems (PACS, RIS,
HIS, etc)
- Medical Devices that contain
software or are software based
- Electronic Devices (both
sterile and non-sterile)
- Catheters, IV Bags
- Surgical Equipment
(including Endoscopes, Scalpels,
etc)
- Cardiac (pacemakers, cardiac
sutures, etc)
- Many low risk devices as
well such as Bandages, Wound
Dressings
- ...many others, too numerous
to list.
Service Specialties include:
- Product Submissions
including: Health Canada MDL, US
FDA 510k, PMA, European
Technical File, etc.
- Quality Management Systems
(QMS), ISO 13485, FDA's QSR,
European MDD, etc
- Sterilization Specialty (ISO
11135, ISO 11137)
- Dealing with FDA/Health
Canada audits (including
response to warning letters,
483s)
- Managing Clinical Trials in
Canada and USA
- We can set you up from
initial product concept right
down to manufacturing and post
marketing activities
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