Our Solutions are Full-Spectrum

We provide leadership, strategy, and execution to clients in the medical device and biotechnology industry where our critical skills are needed the most.

  • Regulatory: We identify regulatory requirements, establish US and global regulatory strategies, author and submit regulatory submissions, and support postmarket compliance. We liaise with US FDA, Health Canada, EU Notified Bodies, and other health authorities.

  • Quality: We develop and maintain Quality Management Systems, Risk Management documentation, and execute internal audits. (ISO 13485 and ISO 14971)

  • Product Development: We support critical product development activities such as selection of appropriate performance standards, nonclinical performance, biocompatibility, and clinical affairs and investigations. (ISO 10993 and ISO 14155)

  • Ad Hoc Consulting: We provide guidance when you need a trusted expert’s advice.

Our Medical Specialty Experience

Our Regulatory, Quality, and Product Development consultants have broad experience supporting medical devices and combination products in many medical specialties, including cardiovascular, dental, dermatology, ear nose and throat, gastroenterology, general and plastic surgery, pathology, neurology, obstetrics and gynecology, ophthalmology, orthopedics, radiology, respiratory, software, and urology.

  • Our consultants have experience supporting cardiovascular medical devices, such as transluminal coronary angioplasty percutaneous catheters.

  • Our consultants have experience supporting the device constituent parts of combination products, such as drug-coated Foley catheter, drug-coated implant, and drug-filled syringes.

  • Our consultants have experience supporting dental medical devices, such as a novel absorbable, implantable material to support dental bone and tissue repair and robotic dental system for cosmetic dentistry.

  • Our consultants have experience supporting dermatology medical devices, such as wound adhesives.

  • Our consultants have experience supporting ear, nose, and throat (ENT) medical devices, such as bronchoscopes, bronchial stents, tracheal stents, tympanic membrane repair, and tympanostomy-tube insertion system.

  • Our consultants have experience supporting gastroenterology medical devices, such as intragastric balloon, colonoscope, gastrointestinal scopes, intubation, colon/rectum stents, duodenum/pylorus stents, and video processors.

  • Our consultants have experience supporting general and plastic surgery medical devices, such as absorbable (Class III) and nonabsorbable (Class II) hemostats, hemostatic device for intraluminal gastrointestinal use, sutures and suture-delivery devices, and cryoablation surgical systems for interventional oncology.

  • Our consultants have experience supporting neurology medical devices, such as intervertebral disc prosthesis, implantable nerve stimulation system for spine, nerve stimulation system for breathing therapy, traumatic brain injury therapy, posterior spinal fixation system, local hypothermia system for brain, and local hypothermia device for spine.

  • Our consultants have experience supporting obstetrics and gynecology (OB/GYN) medical devices, such as a lubricant to treat perimenopausal and menopausal symptoms.

  • Our consultants have experience supporting medical devices, such as intravitreal syringe, implanted keratoprosthesis, and implantable aqueous shunt.

  • Our consultants have experience supporting orthopedics medical devices, such as a posterior spinal fixation system and absorbable, implantable bone void filler comprised with animal-derived materials.

  • Our consultants have experience supporting pathology medical devices, such as whole slide digital imaging system with novel staining agent.

  • Our consultants have experience supporting radiology medical devices, such as AI for breast cancer screening and diagnosis and radiological image processing software.

  • Our consultants have experience supporting Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD).

    Software as a Medical Device (SaMD) products:
    * Radiological AI for breast cancer screening and diagnosis
    * Radiological image processing software as an adjunct to cryoablation and radiofrequency surgery

    Software in a Medical Device (SiMD):
    * Dental robotic system
    * Gastroenterology video processor for endoscopy
    * Neurology spinal stimulation system
    * Pathology whole slide digital imaging system
    * Pulmonary nerve stimulation system
    * Urology liver perfusion system
    * Urology ultrafiltration hemodialysis system

  • Our consultants have experience supporting urology medical devices, such as blood tubing lines, blood filter, dialysate filter, dialyzer, drug-coated Foley catheter, kidney perfusion system, and ultrafiltration hemodialysis system.