Acera is Committed to Setting the Standard for Quality and Compliance
Our Quality Policy: Acera Surgical is committed to patient safety and will provide high quality medical devices, while meeting or exceeding all regulatory requirements and customer expectations, by thoughtfully monitoring the effectiveness of the quality system, and continually improving product and process performance.
Setting the highest standards in the market for ethics and the way our company behaves is extremely important.
- Jake Wilson, CEO Emeritus & Board Member of Acera Surgical
Acera’s Quality System was established based upon the requirements of the following regulations and standards:
- United States Food and Drug Administration (FDA), Quality System Regulation, 21 CFR Part 820 and its referenced parts
- ISO 14971:2019, Medical Devices – Application of risk management to medical devices
- ISO 13485:2016, Medical Devices – Quality management systems - Requirements for regulatory purposes
Restrata Sheet eIFU
| Item # |
Size & Configuration |
Coverage (cm2) |
eIFU |
| RWM1-0.5X1 |
1.3 x 2.5 cm sheet |
3.25 |
For a downloadable version
of the IFU, please click here:
MKG-20002-14
|
| RWM1-1X1 |
2.5 x 2.5 cm sheet |
6.25 |
| RWM1-1X2 |
2.5 x 5 cm sheet |
12.5 |
| RWM1-1.5X2 |
3.8 x 5 cm sheet |
18.5 |
| RWM1-1X3 |
2.5 x 7.5 cm sheet |
18.75 |
| RWM1-2X2 |
5 x 5 cm sheet |
25 |
| RWM1-3X3 |
7.5 x 7.5 cm sheet |
56.25 |
| RWM1-4X5 |
10 x 12.5 cm sheet |
125 |
| RWM1-5X7 |
12.5 x 17.5 cm sheet |
225 |
Restrata Mesh eIFU
| Item # |
Size & Configuration |
Coverage (cm2) |
eIFU |
| RMESH-1.5x2 |
3.8 x 5 cm meshed |
19 up to 38 |
For a downloadable version
of the IFU, please click here:
MKG-20002-14
|
| RMESH-2x2 |
5 x 5 cm meshed |
25 up to 50 |
| RMESH-3x3 |
7.5 x 7.5 cm meshed |
56 up to 112 |
| RMESH-4x5 |
10 x 12.5 cm meshed |
125 up to 250 |
| RMESH-5x7 |
12.5 x 17.5 cm meshed |
225 up to 450 |
Restrata MiniMatrix eIFU
| Item # |
Size & Configuration |
Coverage (cm2) |
eIFU |
| RMINI-100 |
100 mg micronized |
10 up to 20 |
For a downloadable version
of the IFU, please click here:
MKG-20007-02
|
| RMINI-250 |
250 mg micronized |
25 up to 50 |
| RMINI-500 |
500 mg micronized |
50 up to 100 |
| RMINI-1000 |
1,000 mg micronized |
100 up to 200 |
| RMINI-2000 |
2,000 mg micronized |
200 up to 400 |
Reference List
1. MacEwan MR, MacEwan S, Wright AP, Kovacs TR, Batts J, Zhang L. Comparison of a Fully Synthetic Electrospun Matrix to a Bi-Layered Xenograft in Healing Full Thick-ness Cutaneous Wounds in a Porcine Model. Cureus. 2017;9(8):e1614. Published 2017 Aug 27. doi:10.7799/cureus.1614.
2. MacEwan MR, MacEwan S, Kovacs TR, Batts J. What Makes the Optimal Wound Healing Material? A Review of Current Science and Introduction of a Synthetic Nanofabricated Wound Care Scaffold. Cureus. 2017;9(10):e1736. Published 2017 Oct 2. doi:10.7799/cureus.1736
3. Sallade E, Grimes D, Jeng L, et al. (December 06, 2023) Antimicrobial Effectiveness Testing of Resorbable Electrospun Fiber Matrix per United States Pharmacopeia (USP) <51>. Cureus 15(12): e50055. doi:10.7759/cureus.50055
4. Part 58-good laboratory practice for nonclinical laboratory studies. (2023). Accessed: November 2023: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-58.
5. Schneider, LA., et al. Arch Dermatol Res 298 (2007): 413-420.
6. Kruse, CR., et al. Wound Repair and Regeneration 23 (2015): 456-464
7. EDS-70023 (Data on file)
8. Regulski MJ, MacEwan MR. Implantable Nanomedical Scaffold Facilitates Healing of Chronic Lower Extremity Wounds. Wounds. 2018;30(8): E77-E80\
9. Fernandez L, Schar A, Matthews M, Kim PJ, Thompson C, Williams N, Stutsman M. Synthetic Hybrid-Scale Fiber Matrix in the Trauma and Acute Care Surgical Practice. Wounds. 2021 Sep;33(9):237-244. PMID: 34734842.
10. Data on File (GPSDP- Oct26-26-2022- FDA Executive Summary Absorbable Synthetic Wound Dressings)
11. EDS-60105 Hybrid-Scale Fiber Definition.
12. MKG-20002-14
13. Acera Surgical Clinical Compendium. https://acera-surgical.com/pages