[bt_bb_section layout=”wide” lazy_load=”yes” allow_content_outside=”no” show_video_on_mobile=”” top_spacing=”” bottom_spacing=”” full_screen=”” vertical_align=”top” color_scheme=”dark-gray-skin” background_color=”” background_image=”” background_overlay=”” top_section_coverage_image=”” bottom_section_coverage_image=”” parallax=”” parallax_offset=”” background_video_yt=”” yt_video_settings=”” background_video_mp4=”” background_video_ogg=”” background_video_webm=”” responsive=”” publish_datetime=”” expiry_datetime=”” el_id=”” el_class=”” el_style=””][bt_bb_row column_gap=”” row_width=”boxed_1200_left_right_content_wide” color_scheme=”” background_color=”” opacity=”” responsive=”” publish_datetime=”” expiry_datetime=”” el_id=”” el_class=”” el_style=”” border=”” animation=”fade_in move_right” shape=””][bt_bb_column lazy_load=”yes” width=”1/4″ align=”left,;,,;,,;,,;,” vertical_align=”top” animation=”no_animation” background_image=”3479″ inner_background_image=”” color_scheme=”” background_color=”” inner_background_color=”” opacity=”” responsive=”” publish_datetime=”” expiry_datetime=”” el_id=”” el_class=”” el_style=”position: relative;” padding=”normal” top_border=”” bottom_border=”” left_border=”” right_border=”” border_color=”” inner_color_scheme=”” shape=”” details=”right-inner” details-color=”white” order=”0,;,,;,,;,,;,”][/bt_bb_column][bt_bb_column lazy_load=”yes” width=”2/4″ align=”left” vertical_align=”middle” animation=”no_animation” background_image=”” inner_background_image=”” color_scheme=”” background_color=”#ffffff” inner_background_color=”” opacity=”” responsive=”” publish_datetime=”” expiry_datetime=”” el_id=”” el_class=”” el_style=”” padding=”20″ top_border=”” bottom_border=”” left_border=”” right_border=”” border_color=”” inner_color_scheme=””][bt_bb_separator top_spacing=”” bottom_spacing=”large” border_style=”none” border_width=”” responsive=”” publish_datetime=”” expiry_datetime=”” el_id=”” el_class=”” el_style=”” text=”” border_color=”none” opacity=””][/bt_bb_separator][bt_bb_headline font_subset=”latin,latin-ext” superheadline=”Services” headline=”Medical Device Testing” subheadline=”BSR offers services for Medical Device development and testing for during R&D, for FDA premarket submission and for marketing purposes.” html_tag=”h2″ align=”inherit%$%%$%%$%%$%” dash=”none” color_scheme=”alternate-dark-skin” color=”” supertitle_position=”” font=”inherit” font_size=”” url=”” target=”_self” responsive=”” publish_datetime=”” expiry_datetime=”” el_id=”” el_class=”” el_style=”” size=”normal” font_weight=”” supertitle_font_weight=”” subtitle_font_weight=”” superheadline_font_weight=”” subheadline_font_weight=”” animation=”no_animation”][/bt_bb_headline][bt_bb_separator top_spacing=”normal” bottom_spacing=”normal” border_style=”solid” border_width=”” responsive=”” publish_datetime=”” expiry_datetime=”” el_id=”” el_class=”” el_style=”” text=”” border_color=”none” opacity=””][/bt_bb_separator][bt_bb_text]
Medical Device Testing is chief among our core services. Biofyl Scientific Research has extensive experience with both 510K and PMA application testing for CDRH or CBER review. We conduct independent comparative testing and substantial equivalence testing for FDA clearance/approval studies. A big percentage of medical device testing for FDA approved and developing autologous blood (CEBR) or bone marrow (CDRH) devices was done by BSR.
For Platelet-Rich Plasma and Bone Marrow concentrate production, BSR also offers protocol development and optimization services. We provide preliminary evaluations to establish baseline performance of devices for in-house quality control and assurance, as well as for marketing purposes. We also provide services for the optimization of centrifugation protocols in platelet and stem cell concentrate processing, using critical cell parameters as primary outcomes.
Have a question regarding this service? Click here to head to our contact page and form.
In addition Biofyl Scientific Research also offers the following services:
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