R&Q Resources

Why R&Q?
Services
EU MDR
CERs
Resources
Careers
Contact

proposals | This is where you'll find our webinars, events, 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 (3)
BPA (1)
brain cancers (1)
Brain disease (1)
brazil (1)
Breast Cancer (2)
breast cancer screening (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 (4)
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)

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

Are you signed up for updates? Subscribe here.

sort

proposals, EU, FDA, CE Marking, European Union, new legislation, FDASIA, September

More changes heading our way?

After a recent statement by the EU health commissioner, it appears that..

VIEW MORE BLOG POSTS

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

Why R&Q?
EU MDR
CERs
Resources
Careers
Contact

Services

- Regulatory
- Quality systems
- Design assurance
- Product quality
- Post-market surveillance
- Remediation