R&Q Resources

Why R&Q?
Services
Remote Support
Resources
Careers
Contact

Upcoming and on-demand education, commentary from thought leaders, Q&A features, and more.

10993 (1)
10993-1 (1)
13485 (1)
14971 (1)
2012 Medical Innovation Summit (1)
2013 (1)
21 cfr (3)
21 cfr 820 (3)
23andMe (1)
3d printing (2)
483 (2)
510(k) (22)
510(k) review (4)
510(k) submission (3)
60 minutes (1)
62304 (1)
AAMI (1)
acha (1)
Acquisitions (1)
acronyms (1)
active implantable medical device (1)
additive manufacturing (1)
adult congenital heart association (1)
advamed (5)
Adverse Event (2)
adverse events (2)
aeds (1)
affordable care (1)
Affordable Care Act (3)
AGILE (2)
alarm systems (2)
alarms (1)
Alexandra Drane (1)
algorithm (1)
AliveCor (1)
Allergy (1)
alternative materials (1)
american medical association (1)
american red cross (1)
Android (6)
angel group (1)
Angel Investors (1)
annoyance (1)
ANVISA (1)
app development (1)
application development (1)
approval time (1)
Apps (6)
argentina (1)
Artificial (1)
artificial knee (1)
Artificial Organ (1)
Artificial Pancreas (1)
ASTM (1)
audit (2)
auditee (1)
audits (3)
Australia (1)
autonomy (1)
aycan mobile (1)
barco (1)
barcodes (1)
best practices (1)
Biocompatibility (3)
biodegradable (1)
biodegradable circuits (1)
biological evaluation (1)
biological product (2)
Biologics (1)
biomechanics (1)
BIOMEDevice (1)
biomedical (2)
Biomedical Industry (1)
Bionic (1)
bionic eye (1)
BioOhio (3)
biosense (2)
bipartisan (1)
bipartisan support (1)
bipartisan vote (1)
birth defect (1)
Blackberry (2)
bodymedia (1)
Boston (4)
BPA (1)
brain cancers (1)
Brain disease (1)
brazil (1)
Breast Cancer (2)
breast cancer screening (1)
Brexit (1)
BSI (1)
budget resolution (1)
business risk (1)
buttons (1)
Cadence Biomedical (1)
calibration (1)
California (1)
calorie burn (1)
Canada (2)
cancer (3)
cancer survivor (2)
CAPA (2)
CAPA remediation (1)
cardiac emergency (1)
Careers (5)
Caronia (1)
Case Studies (9)
Catheter Valley (1)
CDER (2)
CDRH (6)
CE Mark (1)
CE Marking (1)
CER (5)
CERs (4)
change in contract manufacturer (1)
change in country of origin (1)
chd (1)
children's heart foundation (1)
China (2)
Christmas (1)
circuits (1)
class iia (1)
cleveland (1)
Cleveland Clinic (3)
Clinical Evaluation Report (3)
Clinical Evidence (1)
Clinical Studies (4)
cmdr (1)
cochlear implant (1)
cochlear implants (1)
collaboration (1)
collective experience (1)
combination product (1)
Combination Products (4)
comparative effectiveness research (1)
Complaint Handling (2)
Complaints (2)
compliance (10)
comprehensive regulatory assistance (1)
computed tomography (1)
computer file (1)
Conferences (3)
congenital heart defect (1)
congenital heart defects (2)
congenital heart disease (1)
congenital heart walk (1)
consulting (1)
corporate policy (1)
corporate quality (1)
correction (1)
corrective action (2)
country code (1)
Courses (1)
Creativity (1)
crowd source (1)
CT Scanner (1)
culture of quality (1)
curling (1)
current good manufacturing practices (1)
Custom Device Exemptions (1)
customer (2)
customer feedback (1)
customer success (1)
customers needs (1)
cybersecurity (3)
Cyborg (1)
Da Vinci (1)
de novo (1)
DEHP (1)
design considerations (1)
design controls (1)
design dossier (1)
design engineers (1)
Design History File Remediation (1)
design quality (2)
device manufacturers (2)
device submissions (1)
devices (1)
DeviceTalks (1)
DeviceTalks Boston (1)
DeviceTalks Minnesota (1)
DeviceTalks West (1)
Diabetes (2)
diagnosis (1)
diagnosis treatment (1)
Discount (1)
disease management (1)
Disruptive Technology (1)
draft guidance (2)
draft guidance document (2)
Drugs (1)
dual core (1)
due diligence (1)
eCopy (1)
eCopy Program for Medical Device Submissions (1)
Education (1)
EIR (1)
EKG (1)
electrode pads (1)
electrodes (1)
electronic log book (1)
electronic logs (1)
Eliza Corporation (1)
Emergo Group (1)
end user (1)
enforcement actions (1)
Engineered By Women (2)
engineering projects (1)
entrepreneurship (1)
environmental conditions (1)
environments (1)
ergonomics society (2)
ethylene vinyl acetate (1)
EU (14)
EU MDR (23)
Europe (3)
european commission (1)
European Union (3)
Events (18)
Everyday Usability (1)
Excise Tax (3)
executive management team (1)
exit strategy (1)
exposure levels (1)
external auditor (1)
fagan (1)
false positives (1)
fashion (1)
FCC (1)
FDA (86)
fda budget (1)
fda clearance (4)
fda guidance (1)
fda inspection (2)
fda perspectives (1)
fda regulated products (1)
FDA website (1)
FDASIA (5)
Federal Register (1)
fibrillation (1)
final rule (1)
FIO (1)
first to file (1)
first to invent (1)
fitness and health (1)
food and drug administration (1)
food and drug administration fda (1)
Food and Drug Administration Safety and Innovation (1)
Frontiers in Optics (1)
fundamentals of engineering (1)
fundraising event (1)
G95-1 (1)
gathering place (2)
Genome (1)
GHTF (1)
glucose measurements (1)
Glucose Monitor (1)
gmp (2)
good manufacturing practices (1)
google (1)
govenment (1)
governing bodies (1)
government (1)
Graematter (1)
gray area (1)
green movement (1)
guidance (1)
Guidance Document (8)
guidance documents (2)
Halloween (1)
HALT (1)
Harm (1)
harmonized symbols (1)
Hazard (1)
Hazardous Situation (1)
Hazards (1)
health (1)
health applications (1)
health canada (8)
health care industry (1)
Health IT (1)
health management (1)
health spot (1)
healthcare (2)
healthcare innovation (1)
healthcare reform (1)
healthspot (1)
heart block (1)
heart disease (1)
heart foundation (2)
heart rhythms (1)
heart to heart (1)
HeLa (1)
Henrietta Lacks (1)
HIMTA (1)
hip replacement (1)
Holidays (1)
HPFB (1)
Huby (1)
human error (2)
human exposure (1)
human factors (6)
human factors group (1)
human factors standards (1)
idiom (1)
iec 60601 (1)
IEC 62366 (1)
IEEE (1)
ifu (1)
image credit (1)
image viewing software (1)
immediate action (1)
implant device (1)
implantables (2)
improved products (1)
improvements (1)
india (1)
Industry Advice (1)
industry guidance (2)
ingesting medical device (1)
Innovation (8)
innovation center (1)
Innovation Pathway (1)
innovations (3)
Innovative to the Bone (1)
inspection (2)
instructions for use (1)
Insurance (2)
Intellectual Property (2)
Intended Use (1)
interaction (1)
internal auditor (2)
internal audits (2)
international (1)
Intuitive (1)
intuitive responses (1)
investments (1)
investors (2)
iOS (2)
ipad (1)
iPad medical apps (1)
iPhone (8)
iphone 5 (1)
ISO (1)
iso 10993 (2)
ISO 10993-1 (1)
ISO 10993-18 (1)
iso 13485 (10)
iso 14971 (4)
ISO 9001:2015 (1)
iuvo BioScience (2)
IVD (2)
IVDR (2)
Jake O'Donnell (1)
Japan PMDA (1)
jawbone (1)
job (1)
Joseph Juran (4)
journal of the american medical association (1)
juran quality (1)
K97-1 (1)
Kickstart (1)
label (1)
labeling (5)
labeling products (1)
labels (1)
landfill (1)
language development (1)
Larynx (1)
Latex (1)
latex allergy (1)
law (1)
Leachables (1)
Learning (1)
license amendment fax back form (1)
life science industry (1)
Linkedin (1)
listing (1)
literature review (1)
Live! (20)
low heart rate (1)
lumia (1)
M2D2 (1)
magnetic resonance imaging (1)
mammogram (1)
mammograms (1)
management philosophy (1)
management reviews (1)
manual (1)
manufacturing process (1)
March Madness (1)
marketing (1)
massage (1)
massage therapy (1)
massmedic (5)
Materials (1)
maude database (3)
MBAN (1)
md&m (2)
MD&M East (1)
MDD (21)
MDIC (1)
MDR (2)
MDSAP (2)
mdufa (1)
mdufa III (2)
MDUFMA (1)
me too products (1)
med-tech industry (1)
medcity (1)
MEDDEV (1)
meddevice (2)
MEDEV 2.7/1 (1)
Medical Advancement (1)
Medical Alley (2)
medical application (3)
medical applications (3)
medical apps (1)
medical breakthroughs (1)
medical claims (1)
medical corporation (1)
medical device (68)
medical device companies (3)
medical device design (1)
medical device development (1)
Medical Device Directive (3)
Medical Device Directives (1)
Medical Device Establishment Registration and List (1)
Medical Device Excise Tax (1)
medical device field (1)
medical device industry (13)
medical device innovation (1)
medical device innovation consortium (1)
medical device labels (1)
medical device manufacturer (1)
medical device manufacturers (4)
medical device news (2)
Medical Device Report (2)
medical device review (2)
Medical Device Start-up (1)
Medical Device Tax (4)
Medical Devices (46)
medical images (1)
medical imaging (1)
medical industry (1)
Medical Innovation Summit (1)
medical product (1)
medical technology (2)
medicaldevice (7)
medicaldevices (5)
medtech (2)
MedWatch (2)
mexico (1)
mHealth (9)
mhra (1)
microchip (1)
military (1)
Minnesota (5)
Mission (1)
mma (5)
mobile app regulation (1)
mobile application (1)
mobile applications (1)
mobile apps (3)
Mobile Health (5)
mobile medical application (2)
mobile medical applications (16)
mobile medical apps (5)
mobile platform (1)
money (1)
MRI (1)
myfitnesspal (1)
nano (1)
nano technology (1)
nanomaterials (1)
nanotechnology (1)
NASA (1)
natural rubber latex (2)
NBC (1)
NDA (1)
networking (2)
new legislation (1)
new medical devices (2)
New York (1)
New Zealand (1)
News (51)
nexus (1)
nhl (1)
nih (1)
north park (1)
nutrition (1)
observation (1)
occupational safety and health (1)
occupational safety and health administration (1)
occupational safety and health administration osha (1)
off-label (1)
off-label promotion (1)
Ohio (4)
Ombudsman (1)
Omenetto (1)
open source projects (1)
Optical Society (1)
optics (1)
Orthopedic Capital of the World (1)
orthosis (1)
OSA (2)
osha guidelines (1)
oxford performance materials (1)
PA Bio (3)
pacemaker (1)
PACS (1)
pareto chart (1)
pareto principle (1)
partnership (1)
patent (1)
patent application (1)
patent office (1)
patent system (1)
Patents (1)
patient data (1)
Patient Preference (1)
Pediatric (1)
Pennsylvania (1)
personal data (1)
petition (1)
Pharma (2)
Pharmaceuticals (1)
phasers (1)
Philadelphia (3)
phthalate (1)
Phthalates (1)
picture archiving communication system (1)
Pittsburgh (3)
pittsburgh pa (1)
Pittsburgh Social Exchange (1)
pittsburgh tech (1)
Pittsburgh Technology Council (4)
PMA (8)
pma supplement (2)
Podcasts (1)
polyvinyl chloride pvc (1)
post market surveillance (1)
Post Market Vigilance (2)
Pre-Sub (1)
Pre-Submission (1)
Precedence (1)
predicate (1)
premarket submissions (2)
preparing for FDA visit (1)
press release (1)
Preventive Action (2)
princeton (1)
probability (1)
process validation (1)
Product Quality (1)
production quality (1)
promising research (1)
proposals (1)
proposed rule (1)
proposed rules (1)
public comments (1)
public health (1)
pubmed (1)
Q&A (2)
Q-Sub (1)
QMS (5)
qualcomm (3)
quality (8)
quality agreement (1)
quality control (1)
quality control methods (1)
quality engineering (1)
quality improvement system (1)
quality improvement techniques (1)
quality improvements (1)
Quality Intel (1)
quality management (4)
Quality Management System (2)
quality manager (1)
quality policy (1)
quality procedures (1)
quality product (1)
quality solutions (3)
Quality System (6)
quality system procedures (1)
quality systems (3)
quick scan (1)
R&Q (12)
R&Q Hires (1)
race for the place (2)
RAPS (2)
recycling (1)
Refuse to Accept (1)
Regions (1)
registration (3)
registration database (1)
registration triggers (1)
registrations (2)
regulation (1)
regulators (1)
regulatory (15)
Regulatory 101 (4)
Regulatory 201 (1)
Regulatory Affairs (4)
Regulatory and Quality Solutions (1)
regulatory department (1)
regulatory effort (1)
regulatory focus (1)
regulatory harmonization (1)
Regulatory Intel (1)
Regulatory Intelligence (1)
regulatory news (4)
regulatory pathway (2)
Regulatory Pathways (1)
regulatory professionals (1)
regulatory risk (1)
regulatory science (1)
regulatory strategy (3)
regulatory structure (1)
regulatory submissions (1)
Reliability (1)
remediation (6)
requirements (1)
research triangle park (1)
residual risk (1)
Resources (1)
retinal exam (1)
Risk (2)
risk analyses (1)
risk analysis (1)
risk analysis approach (1)
risk level (1)
risk management (4)
Risk-Benefit (1)
Robot-assisted (1)
RQS (7)
rqs cares (1)
RTA (2)
RTCA (1)
runners (1)
running (1)
safety communication (1)
safety feature (1)
safety hazards (1)
scanadu (2)
sdo (1)
security breach (1)
senate committee on finance (1)
sensors (2)
September (1)
Sequence of Events (1)
severity (1)
shock (1)
sigma six (1)
six sigma (2)
Sleep apnea (1)
Small Business (2)
smart phone (1)
smartphones (1)
SMaSh (1)
software (2)
software developers (1)
software development (1)
software platform (1)
software system (1)
software technologies (1)
spider silk (1)
Spider-Man (1)
standard (1)
standard iso (1)
standards (3)
Standards Compliance (1)
standards development organization (1)
star trek (1)
Starbucks (1)
start ups (2)
Start-Up Device (1)
startups (3)
statistical process control (1)
statistical quality control (1)
statistical quality control methods (1)
staying power (1)
Stents (3)
sterilization (1)
Steven Casey (1)
submission (3)
submission type (1)
submissions (4)
Substantial Equivalence (3)
success (1)
sudden cardiac arrest (1)
supplements (1)
supplier evaluations (1)
supplier management (1)
supplier quality (2)
supplier selection (1)
surgery (1)
surgery system (1)
synthetic rubbers (1)
tachycardia (1)
Tax (2)
tax payer dollars (1)
taxes (1)
team members (1)
Technical Documentation (2)
technical specifications (1)
technology (2)
technology advancements (1)
technology hub (1)
telemetry (1)
teleradiology (1)
teq (1)
TGA (2)
therapy (1)
titanic (1)
Top 10 Innovations (1)
Top 10 Medical Innovations for 2013 (1)
touchscreen (1)
trade (1)
trade deadline (1)
trade-off (1)
Training (2)
Transhumanism (4)
Transhumanism - Science from Fiction (4)
trash (1)
tricorder (1)
u s senate (1)
UDI (5)
UMass (1)
Unique Device Identification (1)
Unique Device Identification System (1)
United States vs. Caronia (1)
Universal Sports (1)
us (1)
us patent law (1)
us senate committee (1)
US vs. Caronia (1)
usability (8)
usability engineering (1)
Use Case (1)
User Fee (1)
user guide (1)
Value Chain (1)
vcs (1)
venezuela (1)
Venture Capitalist (1)
venture capitalists (1)
verizon wireless (1)
Veteran's Affairs (1)
Video (1)
visual signal (1)
walkers (1)
warning letter (4)
watch sensors (1)
wearable tech (2)
wearables (2)
webinar (6)
Webinars (38)
weight watchers (1)
wellness products (2)
white paper (2)
WIB (1)
wikipedia (1)
Windows 8 (1)
windows millenium (1)
wireless medical device (1)
Women in Bio (4)
workouts (1)
Workshops (2)
www.fda.gov (1)
x prize (1)
x prize foundation (1)
x-ray (1)

Live (9)
Webinars (9)
Live! (9)
Events (3)
News (1)

Not signed up for updates?

Subscribe here.

sort

me too products, FDA, medical device, success, Innovation, Innovation Pathway

Success as an innovator

How can you be successful as an innovator?

VIEW MORE BLOG POSTS

info@rqteam.com
+1 (877) 652-0830
HQ: 2790 Mosside Blvd #800
Monroeville, PA 15146

Why R&Q?
Remote Support
EU MDR / IVDR
CERs / PERs
Resources
Careers
Contact

Services

- Regulatory
- Quality Systems
- Quality Assurance
- Post-Market Surveillance
- Remediation
- Project Management

FS 565132