Beebrox consulting
Keeping you
up to date with
medical standards
“Everything can always be better.”
How can we help?
ESTABLISH QUALITY MANAGEMENT SYSTEMS
The scope of your business activities along with your products or services determine requirements for documentation outputs, validation activities, and process requirements. We can help with an audit report that will help you visualize potential deficiencies. EN ISO 13485:2016 is our guidance.
GUIDANCE ON MEDICAL STANDARDS
Are you building a new product or transitioning an old one to new regulations? We can help with holistic examination and help you understand the requirements for your case. We can assist with consulting your team, or offer to revise your design.
Trust the expert
Boštjan Barbiš is a medical engineer, with experiences in the industry and medical research field. Put your project in capable hands of someone who will highlight all those little things you forgot to think about.
RISK MANAGEMENT TECHNIQUES
We can consult your team on recognized regulatory practices. In addition to that, we can include manufacturing related risks and help you understand control measures where they apply to you.
TECHNICAL FILE CONTENT
By auditing your case we can create preliminary TF content and reference all other requirements to it. On this point, you can complete the TF yourself or we can assist you further. Available also for MDR 715:2017.
CLINICAL RESEARCH
If you are unsure if your device specification can comply with existing clinical literature we can set up a pre-audit to detect risks in your current design.
BIOCOMPATIBILITY SOLUTIONS
We have many experiences with biocompatibility evaluations and skin contact solutions. We can help you with reports, testing or offer you our own solutions. If you need a solution for your batch of prototypes, we can offer the solution of biocompatible 3D printing.
AUDIT
Performing annual audits is an obligatory practice. We can help you use them as an opportunity to improve.
CONSULTANCY OUTPUTS
We sign NDA that protects both parties and foresee feasibility of our cooperation.
If unclear we do a GAP analysis of your current state. We propose solutions and report initially detected risks.
Together we decide what to do next after your motivations are clear.
“100% growth in industry of wearables is predicted by 2022.”
Are you an investor?
Bioelectromagnetics drive
diagnostics and medical treatments
of tomorrow.
Making difficult projects happen
Trusted By Doctors, Innovators & Enterprises
Mutual trust, long-term partnership and exciting joint plans are what we strive for. We are proud and honored to have many innovative companies working with us.
