Empowering The World
With A Revolutionary Powder
With A Revolutionary Powder
Compliance
Regulatory Status
Biolife was initially granted FDA (510k) clearance (Premarket Notification: K070520) to market the powder technology in October
23, 2007 for the treatment of minor external bleeding from wounds and medical procedures. Biolife was further granted FDA
(510k) clearance (Premarket Notification: K080210) on February 10, 2009 for expanded application to include treatment for
moderate to severe external bleeding wounds. The powder has passed all required safety, toxicity and biocompatibility testing.
As new healthcare indications emerge, Biolife is preparing and submitting additional 510k filings as required.
Regulations and Licensure
Biolife's powder products are distributed in accordance with current US FDA Regulations. The powder is a Health Canada Class
II Medical Device (wound dressing, hydrophilic, for wound exudates absorption) and, therefore, requires licenses for distribution.
Biolife powder products can be distributed in Europe as a Class IIa under Annex V and VII Rule 4.
Performance Testing
The powder successfully induces hemostasis by fluid dehydration, protein coagulation and agglomeration. Safety and efficacy
has been demonstrated for bleeding control in vascular access procedures using a swine model both acutely and
subchronically. Efficacy was also tested clinically in a comparative evaluation of noninvasive compression adjuncts for
hemostasis in peripheral arterial, venous and arteriovenous dialysis access procedures. Biolife, LLC believes that, as a result of
the biocompatibility testing, in vitro testing, and non-clinical animal testing, BioSeal/WoundSeal Powder is safe and effective as
an aid in the control of external bleeding associated with minor to traumatic wounds.
Safety & Efficacy Testing
STS Duotek (now Moog), an independent, FDA registered laboratory that routinely performs Good Laboratory Practice (G.L.P.)
studies for the pharmaceutical and medical device industries, has confirmed and attested to the safety of Biolife's powder
products.
Biocompatibility Testing – Cytotoxicity, Sensitization, Irritation (skin and mucosal surface), Acute Systemic Toxicity, Ames
Mutagenicity, Endotoxin, Pyrogen, Analysis of Hydrophilic Polymer for Styrene, Ethylstyrene and DVB, Histologic Assessment of
Acute PRO QR (BioSeal) Exposure in a Porcine Wound Model, IR Analysis of QR Powder/BioSeal and hydrophilic polymer for
cellulose, XRD and XRF for potassium iron oxyacid salt impurities.
In vitro Testing – Absorption Study, Acid Base Interaction Study, Scanning Electron Microscopy (SEM) Analysis, Potassium (K) and
Iron (Fe) Extraction, Gravimetric Determinations of (BioSeal/WoundSeal), Hemostatic Properties of (BioSeal/WoundSeal) Powder
as a function of its Quantitative Stability-Indicating Moisture and Potassium Iron Oxyacid Salt content.
For a review of clinical research and case studies conducted for BioSeal/WoundSeal, contact us.
Quality Management System
Biolife has established its Quality Management System (QMS) according to the standards and regulations of:
US Department of Health and Human Services, Food and Drug Quality System Regulation, Title 21 of the Code of Federal
Registrations, Part 820.
International Organization for Standardization (ISO) ISO 13485:2003 The Canadian Medical Device Regulations (SOR/98-282).
The Medical Device Directive, MDD 93/42/EEC, Annex I, Annex V and VII.
The scope of the QMS is for the manufacture and distribution of topical hydrophilic dressings for temporary bleeding control
associated with minor cuts, lacerations, skin tears, anterior nosebleeds, vascular access and surgical wounds. Biolife will
comply with the most recent edition of the aforementioned documents and standards as well as new standards that the
Company's Quality / Regulatory Affairs departments deem appropriate. Biolife makes necessary revisions to its Quality
Management System to ensure compliance with all applicable standards.
Biolife management conducts regular audits of the Quality Management System, with both inside and outside company support
as required to assure it is performing in accordance with all regulations. These audits are both scheduled and/or
ad-hoc as required to meet operational requirements and regulatory commitments.
Regulatory Status
Biolife was initially granted FDA (510k) clearance (Premarket Notification: K070520) to market the powder technology in October
23, 2007 for the treatment of minor external bleeding from wounds and medical procedures. Biolife was further granted FDA
(510k) clearance (Premarket Notification: K080210) on February 10, 2009 for expanded application to include treatment for
moderate to severe external bleeding wounds. The powder has passed all required safety, toxicity and biocompatibility testing.
As new healthcare indications emerge, Biolife is preparing and submitting additional 510k filings as required.
Regulations and Licensure
Biolife's powder products are distributed in accordance with current US FDA Regulations. The powder is a Health Canada Class
II Medical Device (wound dressing, hydrophilic, for wound exudates absorption) and, therefore, requires licenses for distribution.
Biolife powder products can be distributed in Europe as a Class IIa under Annex V and VII Rule 4.
Performance Testing
The powder successfully induces hemostasis by fluid dehydration, protein coagulation and agglomeration. Safety and efficacy
has been demonstrated for bleeding control in vascular access procedures using a swine model both acutely and
subchronically. Efficacy was also tested clinically in a comparative evaluation of noninvasive compression adjuncts for
hemostasis in peripheral arterial, venous and arteriovenous dialysis access procedures. Biolife, LLC believes that, as a result of
the biocompatibility testing, in vitro testing, and non-clinical animal testing, BioSeal/WoundSeal Powder is safe and effective as
an aid in the control of external bleeding associated with minor to traumatic wounds.
Safety & Efficacy Testing
STS Duotek (now Moog), an independent, FDA registered laboratory that routinely performs Good Laboratory Practice (G.L.P.)
studies for the pharmaceutical and medical device industries, has confirmed and attested to the safety of Biolife's powder
products.
Biocompatibility Testing – Cytotoxicity, Sensitization, Irritation (skin and mucosal surface), Acute Systemic Toxicity, Ames
Mutagenicity, Endotoxin, Pyrogen, Analysis of Hydrophilic Polymer for Styrene, Ethylstyrene and DVB, Histologic Assessment of
Acute PRO QR (BioSeal) Exposure in a Porcine Wound Model, IR Analysis of QR Powder/BioSeal and hydrophilic polymer for
cellulose, XRD and XRF for potassium iron oxyacid salt impurities.
In vitro Testing – Absorption Study, Acid Base Interaction Study, Scanning Electron Microscopy (SEM) Analysis, Potassium (K) and
Iron (Fe) Extraction, Gravimetric Determinations of (BioSeal/WoundSeal), Hemostatic Properties of (BioSeal/WoundSeal) Powder
as a function of its Quantitative Stability-Indicating Moisture and Potassium Iron Oxyacid Salt content.
For a review of clinical research and case studies conducted for BioSeal/WoundSeal, contact us.
Quality Management System
Biolife has established its Quality Management System (QMS) according to the standards and regulations of:
US Department of Health and Human Services, Food and Drug Quality System Regulation, Title 21 of the Code of Federal
Registrations, Part 820.
International Organization for Standardization (ISO) ISO 13485:2003 The Canadian Medical Device Regulations (SOR/98-282).
The Medical Device Directive, MDD 93/42/EEC, Annex I, Annex V and VII.
The scope of the QMS is for the manufacture and distribution of topical hydrophilic dressings for temporary bleeding control
associated with minor cuts, lacerations, skin tears, anterior nosebleeds, vascular access and surgical wounds. Biolife will
comply with the most recent edition of the aforementioned documents and standards as well as new standards that the
Company's Quality / Regulatory Affairs departments deem appropriate. Biolife makes necessary revisions to its Quality
Management System to ensure compliance with all applicable standards.
Biolife management conducts regular audits of the Quality Management System, with both inside and outside company support
as required to assure it is performing in accordance with all regulations. These audits are both scheduled and/or
ad-hoc as required to meet operational requirements and regulatory commitments.
 | |  | |  | |  | |  |
This site is governed solely by applicable U.S. laws and governmental regulations. Please see our Privacy Policy. Use of this site
constitutes your consent to application of such laws and regulations and to our Privacy Policy. Your use of the information on this site is
subject to the terms of our Legal Notice. Contact Us with any questions or search this site for more information.
© 2012 Biolife LLC. All rights reserved. An ISO 13485:2003 Certified Company ► 941-360-1300 ► 800-722-7559 ► Email US
constitutes your consent to application of such laws and regulations and to our Privacy Policy. Your use of the information on this site is
subject to the terms of our Legal Notice. Contact Us with any questions or search this site for more information.
© 2012 Biolife LLC. All rights reserved. An ISO 13485:2003 Certified Company ► 941-360-1300 ► 800-722-7559 ► Email US
 |
| |
 |
| |
 |
| |
 |
| |
 |