Medical Device Services
. Regulatory Strategies and Submissions
. Clinical Evaluations and Investigations
. Quality Management Systems
. Biological and Material Safety
. Animal Tissue Safety
. Regulatory Strategies and Submissions
. Clinical Evaluations and Investigations
. Quality Management Systems
. Biological and Material Safety
. Animal Tissue Safety
RKP Services offers efficient, responsive expertise for every phase of medical device development . Based in Southern California, we have succesfully helped over 250 clients resolve their challenges in gaining and maintaining market presence for their medical devices. From startups to mature companies, we have expertise to solve tough problems in a timely manner, with over 30 years of expertise in medical device development, with clients ranging from startups to Fortune 500’s.
Regulatory
Directed and implemented regulatory strategies both at industry-leading
corporations as well as small business start-ups, consistently gaining
regulatory approvals. Submission compilation and management including:
- Pre-submission, submission and informational meetings
- Investigational Device Exemption (IDE)
- 513(g) Request for Information
- 510(k) (Premarket Approval)
- Premarket Approval (PMA)
- Early breakthrough Designation Request
- De Novo Request
- Humanitarian Device Exemption (HDE)
- Technical Files/Design Dossiers
- Canadian Medical Device License(s)
Product experience includes Class I, II and III devices in the areas of
orthopedic implants, hemostasis management, animal tissue products,
biologics, cold therapy systems, electro-medical devices (EMS/TENS), dental
lasers, dental instruments, dental implants, infusion pumps, and orthopedics devices, surgical instruments, IVD’s,
cardiovascular, endovascular therapeutic/diagnostic catheters, cardiovascular instruments, electro-surgical instruments,
neuroembolectomy, brachytherapy and mammography systems
Clinical
Clinical evaluations in compliance with MEDDEV 2.7.1 (all revisions), Medical Device Directive (93/42/EC)
and the Medical Device Regulation (2017/746), including literature reviews and clinical risk assessments, specializing in
orthopedic, critical care, ophthalmic, cardiovascular, ophthalmic and neurological devices.
Advise and direct Clinical Study design and monitoring activities. Develop Good Clinical Practice systems and Clinical Evaluation Plans.
Research experience includes medical devices in the areas of orthopedic implants,
hemostasis management, animal tissue products, biologics, cold therapy systems, electro-medical devices (EMS/TENS),
dental lasers, dental instruments, dental implants, infusion pumps, and orthopedics devices, surgical instruments,
imaging systems, monitoring systems, neurointerventional, cardiovascular implants, IVD’s, endovascular
therapeutic/diagnostic catheters, cardiovascular instruments, electro-surgical instruments, neuroembolectomy,
brachytherapy and mammography systems
Quality Management SYstems
Implement Quality Systems to assure domestic and international regulatory compliance at startups companies as well
as well-established firms.
Quality Systems Management applications, including
- ISO 13485:2016, FDA Quality System Regulation,
- MDSAP,
- Medical Device Directive (93/42/EC) and Medical Device Regulation (2017/746) compliance.
Internal and supplier audits , including pre-inspection audits (pre and post approval FDA and Notified Body inspections, Bioresearch monitoring audits).
Design documentation compilation, including Software Validation, Design Control/History Files, and Risk Management
Files. Develop and validate paperless documentation storage and approval systems.
Biological and Material Safety
Biological safety programs, including implant devices, long-term circulating blood contacting devices, and devices
incorporating animal tissues:
- Test protocol development and interpretive analysis of in vitro and in vivo biological safety evaluation
- Analysis of gross pathology and histopathology results
- Prion assessment and validation
- Hazardous material assessment
- Toxicological risk assessment
- Device chemistry
- Chemical constituent characterization and analysis
- Biological contaminants program
- Microcontamination assessment
Analysis of the behavior of biomaterials in the following contexts
- Implant tissue effects
- Hemodynamics
- Coagulation cascade effects
- Thrombogenicity
- Mechanical
- Chemical
Implementation of safety/hazardous material programs, including chemicals
programs (REACH, EC 1907/2006, EC 1272/2008) hazardous materials,
blood borne pathogens programs and tissue handling.
Animal Tissue Safety
Animal tissue safety analysis for:
- Bovine origin tissues and biologics
- Porcine original tissues and derivative materials
- Crustacean original tissues and derivative materials
- Insect original tissue and derivative materials
-
EDQM Certificate of Suitability; TSE
Transmissible Disease (TSE and other zoonotic) Analysis including
- Decontamination methods
- Manufacturing processes
- Material sourcing
- Material Nature/Type
- Clinical exposure routes
- Compliance with EN ISO series 22442
- EU Animal Tissue Regulation 722/2012